Diabetic Atherosclerosis Management Can Be Personalized Using Coronary Artery Calcium Score

MedicalResearch.com Interview with:
Dr. MalikDr. Shaista Malik MD PhD MPH
Director of Samueli Center For Integrative Medicine
Assistant Professor, School of Medicine
University of California, Irvine

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Having diabetes has been considered to be a risk equivalent to already had a myocardial infarction for predicting future cardiovascular events.  We were interested in testing whether further risk stratification in those with diabetes and metabolic syndrome, using coronary artery calcium (CAC), would result in improved prediction of cardiovascular events.

We found that CAC score was associated with incident coronary heart disease and cardiovascular disease more than a decade after the scoring was performed.  We also found that even after we controlled for the duration of diabetes (of 10 years or more), insulin use, or hemoglobin A1c level, coronary artery calcium remained a predictor of cardiovascular events.

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Despite More A1C Testing, Diabetes Control Plateaus

MedicalResearch.com Interview with:
Saeid Shahraz, MD, PhD
Heller School of Social Policy and Management
Brandeis University
Waltham, Massachusetts 

MedicalResearch.com: What is the background for this study?

Response: Previous researchers had shown a significant improvement in diabetes control in the US between the years 1998 and 2010. We wanted to show if the betterment in diabetes control continued after then.

As previously, we measured hemoglobin A1C that shows the extent to which blood glucose level is under control.

Our main finding was that this upward improving trend plateaued for years after 2007 up to 2014, the last year for which we had data. We examined both genders, white and non-white populations as well as three age groups; young, middle age, and elderly population and results were the same: no change.

Overall, in 2007, 14% of patients with diabetes showed a poor diabetes control (Hemoglobin A1C more than 9%) ; in 2014, 15% of patients with diabetes fell within the category of poor diabetes control. 55% of the patients had a Good control of diabetes (Hemoglobin A1C less than 7%) in 2007; this measure was 54% in 2014.

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Children and Young Adults With Diabetes Have Increased Risk of Sudden Cardiac Death

MedicalResearch.com Interview with:
“Diabetes Test” by Victor is licensed under CC BY 2.0Jesper Svane

Medical student
The Heart Center, University Hospital Rigshospitalet
Copenhagen 

MedicalResearch.com: What is the background for this study?

Response: At the beginning of this research project, we were aware that persons with diabetes have an increased risk of death, which is partly explained by an increased risk of sudden cardiac death. However, previous studies on causes of death and mortality among young persons with diabetes, particularly type 2 diabetes, are sparse. Furthermore the incidence of sudden cardiac death among young persons with diabetes in a nationwide setting is unknown.

The main purpose of the study was to illuminate the risk of death and especially the risk of cardiac death among children/young adults with diabetes.

On a personal note, a friend of mine, who was healthy and fit, died suddenly a few years ago at the age of 19. This tragic death raised a lot of feelings as well as questions in me. When I got the chance to work with Dr. Lynge and Dr. Tfelt, I saw this as an opportunity to expand my knowledge of sudden cardiac death among the young. Furthermore, the opportunity of contributing to research in order to prevent these devastating events in the future was personally appealing to me.

I initiated the project together with Thomas Hadberg Lynge, MD, last year, with Jacob Tfelt-Hansen, MD, DMSc as supervisor. Both are experienced researchers within the field of sudden cardiac death. Dr. Tfelt-Hansen leads a very productive research group at Rigshospitalet, Copenhagen, whose main focus is arrhythmias and sudden cardiac death.

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Lifestyle Modifications Slow Progression To Diabetes As Effectively As Medications

MedicalResearch.com Interview with:
Dr. Karla Galaviz PhD
Hubert Department of Global Health
Rollins School of Public Health
Emory University
Sonya Haw, MD| Assistant Professor
Division of Endocrinology, Metabolism & Lipids
Emory University, School of Medicine
Grady Memorial Hospital
Atlanta, GA

MedicalResearch.com: What is the background for this study? What are the main findings?

  • Diabetes affects 1 in 11 adults worldwide and though there is evidence that lifestyle modification (eating healthier diets and exercising about 150 mins a week) and certain medications can prevent or delay diabetes onset, it is not clear which of these strategies offers long-term benefits.
  • To answer this question, we compiled all available randomized controlled trials of lifestyle programs and medications to prevent diabetes and analyzed the data to see if the diabetes prevention effects persisted in the long-term. We specifically compared studies where the lifestyle or drug interventions were discontinued to see if the effect was long lasting or diminished when the intervention was stopped.

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Kidney Failure From Diabetes Decreasing Across US

MedicalResearch.com Interview with:
Nilka Ríos Burrows, MPH, MT (ASCP)
Lead, Chronic Kidney Disease Initiative
CDC Division of Diabetes Translation. 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Kidney failure treated with dialysis or a kidney transplant is called end-stage renal disease (ESRD).  ESRD is a costly and disabling condition often resulting in premature death.

During 2000–2014, kidney failure from diabetes among U.S. adults with diabetes decreased by 33%, and it declined significantly in most states, the District of Columbia, and Puerto Rico. No state experienced an increase in kidney failure from diabetes. Continued awareness and interventions to reduce risk factors for kidney failure, improve diabetes care, and prevent type 2 diabetes might sustain these positive trends.

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Study Finds ACE Inhibitors and Statins Can Be Safe In Type I Diabetes

MedicalResearch.com Interview with:
M. Loredana Marcovecchio, M.D.
Clinical Scientist and
Professor David Dunger M.D.
Director of Research
Professor of Paediatrics
University of Cambridge

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The efficacy and safety of ACE Inhibitors and statins in adolescents have been shown in the context of hypertension and familial hypercholesterolemia, respectively. However, there is a lack of data on the long-term use of these drugs in those with type 1 diabetes and, in particular, there is no clear indication for their use in patients with increased albumin excretion.

The Adolescent type 1 Diabetes cardio-renal Intervention Trial (AdDIT) was a multi-centre, international study, set up by investigators in the UK, Australia and Canada to explore if drugs already used to lower blood pressure (ACE inhibitors) and cholesterol levels (Statins) in adults with diabetes could reduce the risk of kidney, eye and cardiovascular disease in adolescents with Type 1 diabetes.

Neither ACE inhibitors nor statins significantly reduced the albumin-creatinine ratio during the 2-4 year trial period. However, some of the secondary outcomes suggest that the drugs may have important benefits.

Treatment with the ACE inhibitor resulted in a 43% reduction in the rates of progression to microalbuminuria, which was not statistically significant, but it could have important clinical implications. Preventing even intermittent cases of microalbuminuria is known to reduce the future risk of kidney and cardiovascular complications.

Statin therapy led to reduced levels of lipid levels, which could reduce long-term risk for cardiovascular complications.

These findings could translate into long-term benefits, but follow-up of this unique cohort will be essential. The essential biological samples and data provided by the participants will continue to inform our future understanding and our options for effective therapies for this vulnerable group of young people with type 1 diabetes.

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Insulin Pump Therapy May Be Superior to Multiple Injections in Young People With Type 1 Diabetes

MedicalResearch.com Interview with:
Prof. Dr. med. Reinhard Holl
Division of Endocrinology and Diabetes, Medical Faculty
Aachen University, Aachen,
Institute of Epidemiology and Medical Biometry
University of Ulm, Ulm
Germany 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Today there are two accepted strategies to treat type-1 diabetes: pump or multiple daily injections. In a large group of patients we compared both strategies, and our results indicate advantages for pump therapy with fewer severe hypos, fewer events of diabetic ketoacidosis, and better metabolic control.

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Oral Semaglutide As Effective As Injectable In Reducing A1C and Weight Loss

MedicalResearch.com Interview with:

Melanie J Davies CBE MB ChB MD FRCP FRCGP Professor of Diabetes Medicine  NIHR Senior Investigator Emeritus Diabetes Research Centre Leicester Diabetes Centre – Bloom University of Leicester

Prof. Davies

Melanie J Davies CBE MB ChB MD FRCP FRCGP
Professor of Diabetes Medicine
NIHR Senior Investigator Emeritus
Diabetes Research Centre
Leicester Diabetes Centre – Bloom
University of Leicester

MedicalResearch.com: What is the background for this study? What are the main findings?

Response:  This was the first study to test the effectiveness of an oral GLP-1 in patients with type 2 diabetes.

The main findings were that compared to both placebo and a GLP-1, Semaglutide, delivered by sub-cutaneous injection weekly, the oral therapy delivered once a day produced better results than placebo and similar results to injectable GLP-1 with regard to reductions in HbA1c and weight loss.

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Antidepressants in Youth Associated With Increased Risk of Type 2 Diabetes

MedicalResearch.com Interview with:
Mehmet Burcu, PhD, MS
Department of Pharmaceutical Health Services Research
University of Maryland, Baltimore 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Antidepressants are one of the most commonly used psychotropic medication classes in U.S. youth, with serotonin reuptake inhibitors representing a large majority of total antidepressant use in youth.

The most interesting finding was that the current use of serotonin reuptake inhibitors in youth was associated with an increased risk of type 2 diabetes mellitus, and this increased risk intensified further with the increasing duration of use and with the increasing dose. A secondary analysis also revealed that the risk of incident type 2 diabetes was most apparent in youth who used serotonin reuptake inhibitors for longer durations AND in greater daily doses.

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Gestational Diabetes Associated With Greater Risk Of Heart Attack and Stroke

MedicalResearch.com Interview with:

Cuilin Zhang MD, PhD Senior Investigator, Epidemiology Branch Division of Intramural Population Health Research NICHD/National Institutes of Health Bethesda, MD 20817 

Dr. Zhang

Cuilin Zhang MD, PhD
Senior Investigator
Epidemiology Branch
Division of Intramural Population Health Research
NICHD/National Institutes of Health.
Bethesda, MD 20817

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Gestational diabetes (GDM) is a common pregnancy complication. The American Heart Association identifies gestational diabetes as a risk factor for cardiovascular disease (CVD) in women, based on consistent evidence for the relationships between gestational diabetes and subsequent hypertension, dyslipidemia, type 2 diabetes, vascular dysfunction and atherosclerosis. Also, previous studies identify GDM as a risk factor for intermediate markers of CVD risk; however, few are prospective, evaluate hard cardiovascular disease end points, or account for shared risk factors including body weight and lifestyle.

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Studying Benign Pancreatic Tumors May Lead To Ability To Grow Beta Cells To Reverse Diabetes

MedicalResearch.com Interview with:

Andrew F. Stewart MD Irene and Dr. Arthur M. Fishberg Professor of Medicine Director, Diabetes, Obesity and Metabolism Institute Icahn School of Medicine at Mount Sinai New York, NY 10029

Dr. Stewart

Andrew F. Stewart MD
Irene and Dr. Arthur M. Fishberg Professor of Medicine
Director, Diabetes, Obesity and Metabolism Institute
Institute at the Icahn School of Medicine at Mount Sinai
New York, NY 10029

MedicalResearch.com: What is the background for this study?

Response: Diabetes results ultimately from an inadequate number of insulin-producing “beta” cell in the pancreas.  Ideally, these would regenerate when they are lost or damaged, but unfortunately inducing them to regenerate or proliferate has proven impossible until recently.

In 2015 and others we identified the first class of drugs – the harmine analogues – that are able to induce human beta cells to proliferate.  In this study, we wanted to identify additional pathways that can lead to human beta cell proliferation at higher rates than we had been able to induce with harmine.   For this we turned to a rare type of benign (i.e., not malignant, not cancer) tumor of the beta cells in the pancreas called “insulinomas”. These tiny tumors overproduce insulin and cause hypoglycemia (low blood glucose) which in turn causes seizures, loss of consciousness and confusion.  Once they are discovered, then can easily be removed via laparoscopic surgery, and the person is cured.  Since they are so rare, and since they are benign and easily cured, insulinomas have not been included in large genome sequencing studies of patients wit cancer.  However, we reasoned that they must hold the genomic recipe or wiring diagram for inducing human beta cells to replicate, so we perfumed next-generation DNA and RNA sequencing on a large series (38) of insulinomas.

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Liraglutide (SAXENDA) May Lead To Weight Loss By Slowing Stomach Emptying

MedicalResearch.com Interview with:

Prof Michael Camilleri, MD Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER) Mayo Clinic, Rochester, MN

Prof. Camilleri

Prof Michael Camilleri, MD
Gastroenterologist, Professor of Medicine, Pharmacology and Physiology at Mayo Clinic
Clinical Enteric Neuroscience Translational and Epidemiological Research (CENTER)
Mayo Clinic, Rochester, MN

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Liraglutide is approved for treatment of obesity; the precise mechanisms for the beneficial weight loss are unclear. We are interested to learn whether it is possible to identify people who are more likely to benefit from this treatment.

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Gastric Bypass: Half of Diabetic Patients In Remission 12 Years After Surgery

MedicalResearch.com Interview with:
Ted Adams PhD
Adjunct Professor, Internal Medicine
Adjunct Associate Professor, Nutrition & Integrative Physiology
The University of Utah 

MedicalResearch.com: Why did you decide to conduct this study?

Response: The primary aim of the study was to determine the clinical outcomes in patients who underwent gastric bypass surgery.

As NIDDK/NIH continued to fund the study, the aim was extended to determining the durability) long-term outcomes) of gastric bypass surgery when compared to non-surgical, severely obese patients.

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Diabetes In Elderly May Be Overtreated Leading To Hypoglycemia

MedicalResearch.com Interview with:

Matthew L. Maciejewski, PhD Professor in Medicine Division of General Internal Medicine, Department of Medicine Center for Health Services Research Primary Care Durham VA Medical Center Duke University

Dr. Maciejewski

Matthew L. Maciejewski, PhD
Professor in Medicine
Division of General Internal Medicine, Department of Medicine
Center for Health Services Research Primary Care
Durham VA Medical Center
Duke University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Treating diabetes requires balancing the risks of long-term harm from under-treatment with the short-term and long-term harm from potential over-treatment. Randomized trials have shown that the benefits of aggressive glycemic control only begin after at least 8 years of treatment. Yet, the harms of aggressive glycemic control –  hypoglycemia, cardiovascular events, cognitive impairment, fractures, and death – can happen at any time.

In some older people, “deintensification” of diabetes treatment may be the safer route, because of the risks that come with too-low blood sugar. The American Geriatrics Society (AGS) specifically states that medications other than metformin should be avoided when an older patient’s hemoglobin A1c is less than 7.5%, because the risks of hypoglycemia are larger and the potential benefits of treatment are smaller for older adults with diabetes.  Most attention in prior work has focused on undertreatment of diabetes and there has been only limited investigation of patient characteristics associated with overtreatment of diabetes or severe hypoglycemia.

Since the elderly are therefore at greatest risk of overtreatment and Medicare is the primary source of care of the elderly, we examined rates of overtreatment and deintensification of therapy for Medicare beneficiaries, and whether there were any disparities in these rates.  We found that almost 11 percent of Medicare participants with diabetes had very low blood sugar levels that suggested they were being over-treated. But only 14 percent of these patients had a reduction in blood sugar medication refills in the next six months.

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Pandemic Flu May Increase Risk of Type 1 Diabetes In Genetically Predisposed Patients

MedicalResearch.com Interview with:
Paz Lopez-Doriga Ruiz MD, PhD candidate Norwegian Institute of Public Health Department of Non Communicable Diseases OsloPaz Lopez-Doriga Ruiz MD, PhD candidate

Norwegian Institute of Public Health
Department of Non Communicable Diseases
Oslo 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Some case reports have linked pandemic influenza to the development of type 1 diabetes. Other studies have suggested that also respiratory infections may contribute to type 1 diabetes risk.

 Our findings supports a suggested role of respiratory infections in the etiology of type 1 diabetes and influenza virus could be a contributing factor to the development of clinical diabetes, due to stress and inflammation in predisposed individuals.

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Patients Frequently Decline Insulin For About Two Years After Recommendation

MedicalResearch.com Interview with:

Alexander Turchin, MD, MS Director of Quality in  Diabetes in the Division of Endocrinology, Diabetes and Hypertension Brigham and Women's Hospital

Dr. Turchin

Alexander Turchin, MD, MS
Director of Quality in
Diabetes in the Division of Endocrinology, Diabetes and Hypertension
Brigham and Women’s Hospital 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Anecdotally, many clinicians report that their patients with diabetes frequently decline recommendations to start treatment with insulin. However, until now, there was no systematic information available on this phenomenon.

Our study has found that 30% of patients initially decline their healthcare providers’ recommendation to start insulin therapy. Patients who do ultimately start treatment with insulin, do it on average more than two years after initially declining it.

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Low-Fat Dairy Products Linked To Decreased Abdominal Fat, Increased Lean Body Mass

MedicalResearch.com Interview with:

Dr Nita Forouhi, MRCP, PhD, FFPHM Programme Leader MRC Epidemiology Unit University of Cambridge School of Clinical Medicine Institute of Metabolic Science Cambridge Biomedical Campus

Dr Nita Forouhi

Dr Nita Forouhi, MRCP, PhD, FFPHM
Programme Lead & Consultant Public Health Physician
MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine
Institute of Metabolic Science
Cambridge Biomedical Campus, Cambridge

MedicalResearch.com: What is the background for this study?

Response: Past research has shown a beneficial link between some dairy products and risk of developing type 2 diabetes, but the mechanisms are not well understood. Body composition (total fat and lean mass) has been suggested as one pathway for the link, but the distribution of body fat and lean mass in relation to dairy consumption is not well studied. Based on this research gap, we aimed to investigate associations between types of dairy consumption and markers of body fat and lean mass distribution including: peripheral fat, the ratio of visceral (fat that surrounds the body organs) to abdominal subcutaneous fat (fat that accumulates under the skin) and appendicular lean mass (i.e., in the limbs).

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Regular Use of Artificial Sweeteners May Worsen Blood Glucose Control

MedicalResearch.com Interview with:

Dr. Richard L. Young PhD Associate Professor Adelaide Medical School The University of Adelaide Group Leader, Intestinal Nutrient Sensing Group Centre for Nutrition & Gastrointestinal Diseases South Australian Health & Medical Research Institute North Terrace, Adelaide | SA 

Dr. Young

Dr. Richard L. Young PhD
Associate Professor Adelaide Medical School
The University of Adelaide
Group Leader, Intestinal Nutrient Sensing Group
Centre for Nutrition & Gastrointestinal Diseases
South Australian Health & Medical Research Institute
North Terrace, Adelaide | SA

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This study was a clinical trial in healthy subjects dosed a sweetener combination (sucralose and acesulfame-K) at a  dose to equal 1.5 L of artificial sweetened drink per day. This was given in capsules to dissolve in the proximal intestine (3 capsules per day, 2 weeks) and was a randomised, placebo-controlled double-blind study.

Sweetener treatment increased glucose absorption (assessed by serum 3-O-methy glucose), increased glycemic responses to duodenal glucose infusion and decreased GLP-1 responses.

These data show that intake of these sweeteners in healthy subjects may increase glycemic responses, and are the first to document an effect of these sweeteners to increase glucose absorption in humans.

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Risk of Type 2 Diabetes Elevated in Women With PCOS – Polycystic Ovary Syndrome

MedicalResearch.com Interview with:

Dorte Glintborg Overlæge, ph.d, dr.med Endokrinologisk Afdeling M Odense Universitetshospital

Dr. Glintborg

Dorte Glintborg
Overlæge, ph.d, dr.med
Endokrinologisk Afdeling M
Odense Universitetshospital

MedicalResearch.com: What is the background for this study?

Response: Polycystic ovary syndrome (PCOS) is a common endocrine disorder. PCOS is most often defined according to the Rotterdam criteria, which include irregular ovulation, biochemical/clinical hyperandrogenism, and/or polycystic ovaries when other etiologies are excluded. PCOS is associated with insulin resistance and obesity, but data regarding development and risk factors for type 2 diabetes (T2D) in PCOS are limited.

We performed a National Register-based study on Danish women with PCOS and included data regarding T2D events according to diagnosis codes and filled medicine prescriptions (N=18,477). Three age-matched controls were included per patient (N=54,680).

MedicalResearch.com: What are the main findings?

Response: We found that the risk for development of type 2 diabetes was 4 times increased in women with PCOS compared to controls. The median age at diagnosis of  type 2 diabetes was 31 years in women with PCOS compared with 35 years in controls suggesting that T2D was diagnosed 4 years earlier in PCOS. Increasing body mass index was associated with increased risk of development of T2D, whereas higher number of births was negatively associated with development of type 2 diabetes.

MedicalResearch.com: What recommendations do you have for future research as a result of this study?

Response: Further studies are needed regarding predictors of  type 2 diabetes in PCOS. Our data support a considerable increased risk for type 2 diabetes in obese women with PCOS. 

MedicalResearch.com: Thank you for your contribution to the MedicalResearch.com community.

Citation:

Development and risk factors of type 2 diabetes in a nationwide population of women with polycystic ovary syndrome

Katrine Hass Rubin Dorte Glintborg Mads Nybo Bo AbrahamsenMarianne Andersen

The Journal of Clinical Endocrinology & Metabolism, jc.2017-01354,https://doi.org/10.1210/jc.2017-01354

Published29 August 2017

Note: Content is Not intended as medical advice. Please consult your health care provider regarding your specific medical condition and questions.

 

 

 

 

 

Victoza® Receives FDA Approval To Reduce Heart Attack and Stroke in Patients With Type 2 Diabetes and Heart Disease

MedicalResearch.com Interview with:

Todd Hobbs, MD Vice President and Chief Medical Officer Novo Nordisk North America

Dr. Hobbs

Todd Hobbs, MD
Vice President and Chief Medical Officer
Novo Nordisk North America 

MedicalResearch.com: Would you tell us a little about liraglutide? How does it work to control diabetes/blood sugar? 

Response: Victoza® (liraglutide) is a human glucagon-like peptide-1 (GLP-1) analog that was approved by the U.S. Food and Drug Administration (FDA) in 2010 to help lower blood sugar in adults with type 2 diabetes. Victoza® is the #1 prescribed (GLP-1) receptor agonist.

Victoza® is a non-insulin, once-a-day medication that helps lower blood sugar levels in adults with type 2 diabetes by increasing glucose-dependent insulin release, inhibiting glucagon secretion, and slowing gastric emptying.

On August 25, the FDA approved a new indication for Victoza®, making it the only type 2 diabetes treatment approved to reduce the risk of major adverse cardiovascular (CV) events, heart attack, stroke and CV death, in adults with type 2 diabetes and established CV disease.

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Liver Key To Development of Diabetic Vascular Complications

MedicalResearch.com Interview with:

Dr. Mauricio Berriel Diaz Deputy Director & Head of Division Metabolic Dysfunction and Cancer Institute for Diabetes and Cancer IDC Helmholtz Center Munich and Joint Heidelberg-IDC Translational Diabetes Program Heidelberg University Hospital, Molecular Metabolic Control Medical Faculty, Technical University Munich Neuherberg, Germany

Dr. Berriel Diaz

Dr. Mauricio Berriel Diaz
Deputy Director & Head of Division Metabolic Dysfunction and Cancer
Institute for Diabetes and Cancer IDC
Helmholtz Center Munich and
Joint Heidelberg-IDC Translational Diabetes Program
Heidelberg University Hospital, Molecular Metabolic Control
Medical Faculty, Technical University Munich
Neuherberg, Germany 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Our institute takes part in a german collaborative research consortium (https://www.klinikum.uni-heidelberg.de/index.php?id=132204&L=1), in which the key objective is to understand why in diabetes mellitus late complications occur even when blood sugar is well controlled.

Our study focused the role of the liver and of inflammatory signaling, as the latter is known to be increased in metabolic diseases such as obesity and diabetes mellitus. We found that TNF-α-induced reactive oxygen species (ROS) formation in the liver abolished the function of the transcription factor GAbp. Impaired hepatic GAbp function resulted in transcriptional inactivation of the cellular energy sensor AMPK, which in turn induced hepatic cholesterol secretion, hypercholesterolemia and eventually atherosclerotic lesion formation.

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Neonatal Hypoglycemia Linked To Neurodevelopmental Outcomes at 4.5 Years

MedicalResearch.com Interview with:

Jane E. Harding, DPhil Liggins Institute The University of Auckland Auckland, New Zealand

Prof. Harding

Jane E. Harding, DPhil
Liggins Institute
The University of Auckland
Auckland, New Zealand

MedicalResearch.com: What is the background for this study?

Response: Neonatal hypoglycaemia – low blood sugars in newborns – affects up to one in six babies born. It involves a sustained dip in blood sugar levels following birth. Blood glucose is the only fuel for babies’ brains (adults have alternative, back-up sources). So, if left untreated, this condition can cause developmental brain damage and lowered education outcomes later in life.

In developed economies, as many as a third of babies born are at risk. Risk factors include being born smaller or larger than usual, preterm babies and babies whose mothers have any form of diabetes – this last a growing group, with the rising incidence of gestational (pregnancy-related) diabetes.

We wanted to systematically track a cohort of babies to see if hypoglycaemia in babies affects their long-term health and development. So we designed the CHYLD study – Children with Hypoglycaemia and their Later Development. We are following 614 New Zealand babies born at risk of low blood sugar levels (neonatal hypoglycemia) into childhood to see if the condition affects their later growth and development. Our team includes researchers from the Liggins Institute, the University of Auckland, Waikato Hospital, the University of Canterbury and the University of Waterloo.

Half of the babies in the study were diagnosed with, and treated for low blood sugars. Seventy percent received extra, continuous monitoring of their blood sugar levels, which detected in some babies low levels that were not diagnosed by the heel-prick tests.

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Diabetes Medication Exenatide Shows Promise In Treating Parkinson’s Disease

MedicalResearch.com Interview with:
Dr Dilan Athauda MRCP
Sobell Department of Motor Neuroscience and Movement Disorders
UCL Institute of Neurology & The National Hospital for Neurology and Neurosurgery
London

MedicalResearch.com: What is the background for this study?

Response: Exenatide is a synthetic version of a naturally occurring protein – exendin-4 – that was originally discovered by Dr John Eng in the early 1990’s in the saliva of the Gila Monster, a venomous lizard native to the Southwestern United states. He and his team were looking for bio-active peptides in insect and lizard venom that could be useful for people with Type 2 diabetes. They discovered that exendin-4 was extremely similar to a human hormone called Glucagon-like peptide-1 (GLP-1).  In humans, GLP-1 is secreted after you eat a meal to stimulate insulin secretion (and inhibit glucagon production) of which the end result is a lowering of blood sugar. Unfortunately human GLP-1 is rapidly broken down by a circulating enzyme called dipeptidyl peptidase IV (DPP-IV) and its effects only last minutes.

Importantly, it was discovered that exendin-4 is naturally resistant to the actions of this enzyme, meaning it’s effects on blood sugar control lasts much longer in the body.  These properties made it very attractive to people trying to treat people with Type 2 diabetes and following many successful randomised controlled trials of patients with Type 2 diabetes in 2005, exenatide was approved for use as a treatment.  During this time, work led by Nigel Greig’s group at the NIA showed that first evidence that exendin-4 had neuroprotective properties, and could protect neurons from a variety of stresses and could also improve growth and rescue degenerating cells. Over the next few years, various groups used exendin-4 in a variety of animal toxin models of Parkinson’s disease and showed that exendin-4 could halt the progression of Parkinsonism and prevent cell death in these models through beneficial effects on inflammation, mitochondrial function and cell survival.

Based on this encouraging pre-clinical data, Professor Foltynie supervised the first small, “open-label”, human trial of exenatide in patients with Parkinson’s disease.  The team found that patients treated with exenatide for 1 year (in addition to their usual medication) had less decline in their motor symptoms when assessed without their medication compared to the control group (just on their usual medication) and this advantage over the control group was still present 1 year after stopping the exenatide injections.  However, this trial was open-label – patients knew they were getting a (potentially beneficial) experimental therapy and so we couldn’t exclude the fact that placebo effects were explaining some of the results we saw.

As a result of the potentially beneficial results seen in this small open label trial we carried out a double-blind, placebo controlled trial.

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Skin-Grafted Stem Cells May Treat Obesity and Diabetes

MedicalResearch.com Interview with:

Dr. Xiaoyang Wu PhD Ben May Department for Cancer Research The University of Chicago, Chicago, IL

Dr. Xiaoyang Wu

Dr. Xiaoyang Wu PhD
Ben May Department for Cancer Research
The University of Chicago, Chicago, IL

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have been working on skin somatic stem cells for many years. As one of the most studies adult stem cell systems, skin stem cells have several unique advantages as the novel vehicle for somatic gene therapy (summarized also in the paper). The system is well established. Human skin transplantation using CEA device developed from skin stem cells have been clinically used for decades for burn wound treatment, and been proven to be safe the effective.

In this study, we developed a skin 3D organoid culture model to induce stratification and maturation of mouse epidermal stem cells in vitro, which allows us to efficiently transfer engineered mouse skin to isogenic host animals. In the proof of concept study, we showed that we can achieve systematic release of GLP1 at therapeutic concentration by engineered skin grafts.

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Diabetic Retinopathy May Impact Daily Work and Activities

MedicalResearch.com Interview with:

Jeffrey R. Willis MD, PhD 

Dr. Willis

Jeffrey R. Willis MD, PhD
UC Davis Eye Center
University of California, Davis
Sacramento California

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Diabetic retinopathy is one of the leading causes of blindness in the United States.  Yet there is limited national level data on the impact of worsening DR on quality of life and visual function.

Our study aimed to address this knowledge gap by evaluating the functional burden of DR across severity levels, utilizing data from the National Health and Nutrition Examination Survey (NHANES).

We found that one-half of US adults with severe non-proliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR) had difficulty with ≥ 1 visual function task, possibly impacting their daily work/activities.  These patients reported a significantly greater vision-related functional burden relative to those with less severe forms of DR.

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Erectile Dysfunction Should Be a Marker For Diabetes

MedicalResearch.com Interview with:

Damiano Pizzol  Operational Research Unit, Doctors with Africa Cuamm Beira, Mozambique

Damiano Pizzol 

Damiano Pizzol 
Operational Research Unit, Doctors with Africa Cuamm
Beira, Mozambique

MedicalResearch.com: What is the background for this study?

Response: Since the 1970s the association between diabetes and the development of erectile dysfunction has been documented both in animal models and humans Several studies have considered the prevalence of erectile dysfunction in diabetes and the majority agree that the incidence of erectile dysfunction in men with diabetes is two- to three-fold higher than in the general population. It is estimated that erectile dysfunction affects up to 75% of all men with diabetes, it is age correlated and occurs at a younger age in men with diabetes.
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Women With Early Menopause At Higher Risk of Diabetes

MedicalResearch.com Interview with:

Eralda Asllanaj Department of Epidemiology Erasmus University Medical Center Rotterdamthe Netherlands

Eralda Asllanaj

Eralda Asllanaj
Department of Epidemiology
Erasmus University Medical Center
Rotterdamthe Netherlands

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: It is known that women with early onset of menopause (age below 45 years) have an increased risk of cardiovascular disease and overall mortality. This increased risk is thought to be due to the adverse effects of menopause on cardiovascular risk factors.

Type 2 diabetes is a major risk factor for cardiovascular disease, but it remains unclear whether age at menopause affects the risk of developing type 2 diabetes. Our study shows that women who experience menopause before the age of 40 were almost 4 times more likely to develop type 2 diabetes than those experiencing menopause after 55 years old. Moreover, those who had menopause between 40 to 44 years were 2.4 times more likely to have diabetes later in life. The risk of having diabetes reduced by 4 % per year older the women experienced menopause. Adjustment for the various confounding factors and differences in genetic predisposition to early menopause did not affect the results.

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Novo Nordisk and Glooko Launch Cornerstones4Care® App To Help Manage Diabetes

MedicalResearch.com Interview with:

David Moore MBA Senior Vice President of Marketing Novo Nordisk 

David Moore

David Moore MBA
Senior Vice President of Marketing
Novo Nordisk 

MedicalResearch.com: What is the Cornerstones4Care Powered by Glooko (C4C) App?

Response: The Cornerstones4Care® Powered by Glooko® App marries Novo Nordisk’s extensive knowledge of diabetes and personalized patient support with Glooko’s digital platform and data analytics expertise. The App is comprehensive tool that helps patients track meals, activity, medicine and blood sugar – in one convenient place – and is intended to help people learn how to better manage diabetes through their mobile devices.

MedicalResearch.com: What functions will people with diabetes have access to? How can the app help people living with diabetes control their disease?   

Response: The Cornerstones4Care® Powered by Glooko® App marries Novo Nordisk’s extensive knowledge of diabetes and personalized patient support with Glooko’s digital platform and data analytics expertise. The App is comprehensive tool that helps patients track meals, activity, medicine and blood sugar – in one convenient place – and is intended to help people learn how to better manage diabetes through their mobile devices.

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Supply and Demand for Diabetes Prevention Programs

MedicalResearch.com Interview with:

Maria L. Alva, DPhil Economist RTI International -  Research Triangle Institute

Dr. Alva

Maria L. Alva, DPhil
Economist
RTI International –  Research Triangle Institute

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We have strong evidence from trials of structured lifestyle intervention programs (e.g. the Diabetes Prevention Program (DPP)) showing that half of new diabetes cases could be avoided if persons with prediabetes changed their lifestyle habits to lose a modest amount of body weight. Moreover, the DPP has been successfully translated into cost-effective community-based prevention interventions, but nationally, these evidence-based interventions (EBIs) are not being used sufficiently. To scale up the implementation of diabetes prevention EBIs, we need to address the challenges of getting organizations to adopt EBIs, and community members to enroll.

Because cost is a primary barrier we wanted to understand what was the perceived value and demand for diabetes prevention programs in NC. And in particular, the role that community health workers and technology could play in program delivery, from the perspectives of both potential recipients (adults at high risk or diagnosed with prediabetes) and decision-makers in healthcare/public health delivery.

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Eyedrop Kallikrein Inhibitor Shows Promise for Diabetic Macular Edema

MedicalResearch.com Interview with:
Dr. David Kita, PhD Founder and Head of R&D Verseon CorporationDr. David Kita, PhD
Founder and Head of R&D
Verseon Corporation

MedicalResearch.com: What is the background for this study?

Dr. Kita: The preclinical data presented at the 2017 BIO International Conference provided details about Verseon’s plasma kallikrein inhibitors for the treatment of diabetic macular edema (DME).

DME affects millions of people worldwide and is a major cause of vision loss in patients with diabetes mellitus. Upregulation of the kallikrein-kinin system in response to diabetes can result in retinal vascular permeability, which can damage the retina and eventually lead to the central vision loss associated with DME.

The current treatment options for DME include intravitreal injections of anti-VEGF agents or corticosteroids into the eye and surgical laser treatments. Long-term use of intravitreal injections is associated with side effects such as inflammation, infections, and cataracts. For anti-VEGF drugs in particular, there is also a growing concern about geographic atrophy. In addition, about 50% of patients reported at most moderate vision improvements following anti-VEGF therapy in clinical trials. This highlights the need for a new treatment that can serve as a monotherapy or as an adjuvant to current therapies.

At Verseon, we are working on inhibitors of the serine protease plasma kallikrein (KLKB1) that can be administered either topically or orally. Verseon’s unique computer-driven drug discovery platform allows us to design potent, selective drug candidates that are unlikely to be found using traditional approaches. We have generated a number of chemically distinct series of KLKB1 inhibitors and optimized multiple lead candidates, which show good activity, permeability, and solubility.

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Newer Insulin Formulation Reduces Risk of Hypoglycemia

MedicalResearch.com Interview with:

Wendy Lane MD Director of Clinical Research Mountain Diabetes and Endocrine Center Asheville, NC 

Dr. Lane

Wendy Lane MD
Director of Clinical Research
Mountain Diabetes and Endocrine Center
Asheville, NC

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The SWITCH1 trial was the first double blinded insulin trial to compare the rate of severe, nocturnal severe and symptomatic blood glucose-confirmed hypoglycemia between two basal insulins, insulin glargine U100 and insulin degludec U100, in patients with type 1 diabetes.

The trial design (double blinded crossover treat-to-target) eliminated any bias in the results, which showed clear-cut reductions in all categories of hypoglycemia with insulin degludec compared to insulin glargine.

Severe hypoglycemia has dangerous and greatly feared consequences including cognitive impairment, seizures, coma and death, and it is the main barrier to effective use of insulin in the treatment of type 1 diabetes. Insulin degludec, which was shown to reduce the risk of hypoglycemia compared to insulin glargine in the SWITCH1 trial, should be viewed by clinicians as an advancement in insulin therapy which will increase its safety and improve the quality of life of our patients with type 1 diabetes.

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Vitamin A Derivative May Have Anti-Diabetic Capabilities

MedicalResearch.com Interview with:

Stefan Amisten, PhD The Oxford Centre for Diabetes, Endocrinology & Metabolism University of Oxford, Oxford Diabetes Research Group, Division of Diabetes & Nutritional Sciences King’s College London, Faculty of Life Sciences & Medicine, London UK

Dr. Armisten

Stefan Amisten, PhD
The Oxford Centre for Diabetes, Endocrinology & Metabolism
University of Oxford, Oxford
Diabetes Research Group, Division of Diabetes & Nutritional Sciences
King’s College London, Faculty of Life Sciences & Medicine, London
UK

MedicalResearch.com: What is the background for this study?

Response: Type 2 diabetes is a global epidemic that is causing an increasing medical and financial burden on both individuals and society in general. Type 2 diabetes is characterized by insulin resistance, poor insulin response to blood glucose which leads to chronically elevated blood glucose and damage to the cardiovascular system and other organs, which may ultimately lead to blindness, kidney failure, blindness, toe amputations, cardiovascular disease and premature death. Although a number of drugs are available for the treatment of Type 2 diabetes, no drug is currently able to cure diabetes, as they are only able to slow down the disease progression. There is therefore a need to develop novel therapies to treat Type 2 diabetes.

G-protein coupled receptors (GPCRs) constitute a family of almost 400 cell surface receptors that is the target of a large number of modern medicines. Interestingly, only a small subset of all GPCRs are currently targeted by modern medicines, which means that a large number of GPCRs still have untapped therapeutic potential, largely because they have not been studied in-depth, or because their ligands (i.e. binding partners) have not been identified.

This study is a result of a thorough cataloguing of all G-protein coupled receptors (GPCRs) in human pancreatic islets (Amisten et al. Pharmacol Ther. 2013 Sep;139(3):359-91.), where the receptor GPRC5C was identified as one of the most abundant orphan GPCRs in human islets.

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PCSK9 Inhibitor Praluent Added to Statins Improved Lipid Profile in Diabetes

MedicalResearch.com Interview with:

Dr-Robert-R-Henry.jpg

Dr. Henry

Robert R. Henry, M.D.
Professor of Medicine
Member of the ODYSSEY DM Steering Committee and
Director of the Center for Metabolic Research
VA San Diego Healthcare System

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The ODYSSEY DM-DYSLIPIDEMIA trial was a randomized, open-label, parallel-group study designed to evaluate the superiority of Praluent versus usual care in 413 patients with type 2 diabetes with mixed dyslipidemia at high cardiovascular (CV) risk, not adequately controlled with maximally tolerated dose (MTD) statins. The primary endpoint was percent change in non-high-density lipoprotein cholesterol (non-HDL-C) from baseline to week 24.

In ODYSSEY DM-DYSLIPIDEMIA, Praluent 75 mg was added to MTD statins, with dose adjusted at week 12 to 150 mg every two weeks if their non-HDL-C was greater than or equal to 100 mg/dL at week 8. Approximately 64 percent of patients reached their lipid goals with the Praluent 75 mg dose.

Results from the ODYSSEY DM-DYSLIPIDEMIA study found that Praluent added to MTD statins showed significant reduction in non-HDL-C and other lipid parameters compared to those on usual care.

Praluent was superior to usual care in lowering non-HDL-C (37.3 percent and 4.7 percent, for the usual care arm). The mean difference between the two treatment arms was -32.5 percent (p<0.0001).

Praluent in combination with MTD statins reduced LDL-C by 43 percent from baseline compared to a 0.3 percent increase for usual care (p<0.0001). Treatment with Praluent also improved the overall lipid profile.

There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Furthermore, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.

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Adding Praluent (Alirocumab) To Statins Reduces LDL in High Cardiovascular Risk Diabetics

MedicalResearch.com Interview with:

Lawrence Leiter, M.D. MDCM, FRCPC, FACP, FACE, FAHA Chair of the ODYSSEY DM Steering Committee and Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute St. Michael’s Hospital University of Toronto, Canada

Dr. Lawrence Leiter

Lawrence Leiter, M.D. MDCM, FRCPC, FACP FACE, FAHA
Chair of the ODYSSEY DM Steering Committee and
Director of the Lipid Clinic at the Li Ka Shing Knowledge Institute
St. Michael’s Hospital
University of Toronto, Canada

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The ODYSSEY DM-INSULIN trial was a randomized, double-blind, placebo-controlled, multicenter study that evaluated alirocumab (Praluent) in 517 patients with insulin treated type 1 and type 2 diabetes with high cardiovascular (CV) risk and hypercholesterolemia despite maximally tolerated dose (MTD) statins. The primary endpoint was percent change in calculated LDL-C from baseline to week 24.

Alirocumab 75 mg every two weeks was added to MTD statins, with the dose increased at week 12 to 150 mg every two weeks if the LDL-C at week 8 was greater than or equal to 70 mg/dL. In fact, only about 20% of the alirocumab treated participants required the higher dose.

Results of the type 2 diabetes study population (n=441) showed that the addition of alirocumab to MTD statin therapy, reduced LDL-C by 48.2 percent from baseline compared to a 0.8 percent increase for placebo. The mean difference between the two treatment arms was -49 percent (p<0.0001). Treatment with alirocumab also improved the overall lipid profile. Furthermore, no new safety issues were identified.

There is a large unmet need for improving cholesterol lowering in patients with diabetes. Despite current standard of care, nearly 70 percent of people age 65 or older with diabetes die from some form of heart disease; and 16 percent die of stroke. Additionally, in spite of current standard of care, many people with diabetes continue to have persistent lipid abnormalities resulting in high residual CV risk.

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Oral Sotagliflozin On Top of Optimized Insulin Significantly Reduced A1C

MedicalResearch.com Interview with:

Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhau

Prof. Danne

Prof. Dr. Thomas Danne
Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc
Kinder und Junden Krankenhaus

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The double-blind, placebo controlled, Phase 3 study known as inTandem2 randomized 782 adult patients from 99 sites in the EU and Israel with type 1 diabetes on insulin pump or multiple daily injection therapy who had an A1C level entering the study between 7.0% and 11.0%. The three-arm study evaluated two doses of sotagliflozin, 200mg and 400mg, each taken once daily before the first meal of the day, against placebo. Prior to randomization, insulin was optimized for all patients over a six-week period, with the objective of improving glycemic control using insulin alone. After completion of this optimization period, patients were maintained on optimized insulin and randomized to one of two doses of sotagliflozin or placebo, and their baseline, post-optimization A1C was measured.

The mean baseline A1C levels after the six-week optimization period were 7.8%, 7.7% and 7.7% for patients randomized to the placebo, 200mg and 400mg arms, respectively (A1C was 8.4% across all dose arms prior to insulin optimization).

The primary endpoint of the study was change in A1C from baseline after a 24-week period of treatment. The trial has a double-blind long term extension of 28 weeks, with a total treatment duration of 52 weeks. There were 258 patients in the placebo arm, 261 patients in the 200mg dose arm and 263 patients in the 400mg dose arm. The overall mean placebo-adjusted A1C reduction at week 24 was 0.36% in the 200mg dose arm (p<0.001) and 0.35% in the 400mg dose arm (p<0.001). In response to regulatory input, a secondary endpoint to measure “net clinical benefit” was defined for this study as the proportion of patients at week 24 who achieved the standard of care A1C goal of less than 7.0% without any episode of severe hypoglycemia or DKA. 15% of patients in the placebo arm, 32% in the 200 mg dose arm and 32% in the 400mg dose arm achieved this endpoint (p<0.001 for both treatment arms).

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Vegetarian Diet More Effective For Weight Loss

MedicalResearch.com Interview with:

Hana Kahleova, MD, PhD</strong> Director of Clinical Research at Physicians Committee for Responsible Medicine Physicians Committee for Responsible Medicine Charles University in Prague

Dr. Kahleova

Hana Kahleova, MD, PhD
Director of Clinical Research at Physicians Committee for Responsible Medicine
Physicians Committee for Responsible Medicine
Charles University in Prague

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The vegetarian diet was found to be almost twice as effective in reducing body weight, resulting in an average loss of 6.2kg compared to 3.2kg for the conventional diet. Using magnetic resonance imaging, we studied adipose tissue in the subjects’ thighs to see how the two different diets had affected subcutaneous, subfascial and intramuscular fat.

We found that both diets caused a similar reduction in subcutaneous fat. However, subfascial fat was only reduced in response to the vegetarian diet, and intramuscular fat was more greatly reduced by the vegetarian diet.

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Home Finger Stick Testing Provided No Health Advantage in Study of Type 2 Diabetics

MedicalResearch.com Interview with:

Katrina Donahue MD, MPH Professor, Director of Research, UNC Family Medicine. Co-Director,  North Carolina Newtork Consortium (NCNC). Chapel Hill, NC

Dr. Donahue

Katrina Donahue MD, MPH
Professor, Director of Research, UNC Family Medicine. Co-Director,
North Carolina Newtork Consortium (NCNC).
Chapel Hill, NC

MedicalResearch.com: What is the background for this study?

Response: Type 2 diabetes is an epidemic affecting one in 11 people in the United States. For those treated with insulin, checking blood sugar with a finger stick at home is an accepted practice for monitoring the effects of insulin therapy.

However, the majority of patients with type 2 diabetes are not treated with insulin. These patients, too, are often recommended glucose monitoring, despite an ongoing debate about its effectiveness in controlling diabetes or improving how patients feel. Currently, 75 percent of non-insulin treated type 2 diabetes patients perform regular blood glucose testing at home, generally at the recommendation of a provider.

“The MONITOR Trial” is the first large pragmatic study examining glucose monitoring in the United States.

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Factors Affecting Interest in Transplant Among ESRD Patients Receiving Dialysis

MedicalResearch.com Interview with:

Deborah Evans, MA, MSW, LCSW Manager, Social Work Services DaVita Kidney Care

Deborah Evans

Deborah Evans, MA, MSW, LCSW
Manager, Social Work Services
DaVita Kidney Care

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: For patients with end-stage renal disease (ESRD) receiving dialysis, receipt of a transplant offers the best possible long-term treatment option. However, the process of becoming qualified to receive a transplant involves many steps, beginning with the patient’s statement of interest.

In this study, we sought to characterize transplant interest among patients in a large dialysis organization in the U.S. and to explore reasons identified by the patients for lack of interest in transplant when applicable.

As of November 2016, of the 182,906 patients with available transplant status information in the LDO database, 58,057 (31.7%) expressed that they were not interested in transplant. Among patients not interested in transplant, the most frequently identified reasons for lack of interest were:

  • Advanced age (25.7%)
  • Perceived poor health (12.0%)
  • Comfortable with current modality (12.0%)
  • Uninterested in further surgeries (11.9%)
  • 13.2% of patients not interested in transplant indicated that “other” factors were responsible for their lack of interest. At the time of the study, we didn’t have any further insight into what might account for these “other” factors.

Compared to patients with transplant status listed as active, those not interested in transplant were:

  • Older (21.4% < 60 years vs 64.6%)
  • More likely to be female (47.7% vs 36.6%)
  • More likely to be white (43.9% vs 30.4%) and less likely to be Hispanic (14.7% vs 22.2%)
  • More likely to be receiving in-center hemodialysis (92.0% vs 73.7%)
  • More likely to have Medicare/Medicaid as primary insurance (91.3% vs. 77.3%)

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Metformin Reverses Some Autism Symptoms In Animal Model

MedicalResearch.com Interview with:
Ilse Gantois, PhD

Research Associate
Dr. Nahum Sonenberg’s laboratory
Department of Biochemistry
McGill University

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Fragile X syndrome (FXS) is a neurodevelopmental disorder characterized by cognitive impairment and affects 1 in 4000 males and 1 in 6000 females. About 60% of persons with Fragile X also have autism spectrum disorder. FXS is caused by absence of Fragile X protein (FMRP), which results in hyperactivation of ERK (extracellular signal-regulated kinase) and mTORC1 (mechanistic target of rapamycin complex 1) signaling. We show that treatment with metformin, the most widely used FDA-approved antidiabetic drug, suppresses translation by inhibiting the ERK pathway, and alleviates a variety of behavioural deficits, including impaired social interaction and excessive grooming. In addition, metformin also reversed defects in dendritic spine morphogenesis and synaptic transmission.
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Pregnant Women Exposed To Cold Temperatures May Have Lower Risk of Gestational Diabetes

MedicalResearch.com Interview with:

Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES)

Dr.Gillian Booth

Dr. Gillian Booth PhD
Researcher at St. Michael’s and the
Institute for Clinical Evaluative Sciences (ICES)

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: The impact of climate change on health is becoming increasingly relevant given the rise in global air temperature, and there is growing evidence supporting a link between air temperature, metabolic function, and energy expenditure. We know from animal models and small studies in humans that cold exposure and activate a type of fat known as brown fat and it appears that this process can improve sensitivity to insulin. However no studies have yet looked at air temperature and the development of diabetes. So we decided to examine the relationship between outdoor air temperature and gestational diabetes – a temporary form of diabetes that arises in the second trimester of pregnancy.

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Fatty Acids From Fish During Infancy May Lower Risk of Type 1 Diabetes

MedicalResearch.com Interview with:

Sari Niinistö, PhD Senior Researcher, Public Health Solutions, Nutrition Unit National Institute for Health and Welfare Helsinki, Finland

Dr. Niinistö

Sari Niinistö, PhD
Senior Researcher,
Public Health Solutions, Nutrition Unit
National Institute for Health and Welfare
Helsinki, Finland

MedicalResearch.com: What is the background for this study?

Response: Previous prospective studies have observed protective association between fish-derived fat and type 1 diabetes related autoimmunity in older children. Also some other fatty acids have been associated with the risk for type 1 diabetes associated autoimmunity. We wanted to study very young children, because type 1 diabetes associated autoimmunity often begins early, already in infancy. Therefore, we investigated whether serum fatty acid levels during infancy or the main dietary sources of fatty acids (breast milk and infant formula) were related to the development of autoimmunity responses among children at increased genetic risk of developing type 1 diabetes.

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Having A Dog Doesn’t Protect Kids From Type 1 Diabetes

MedicalResearch.com Interview with:

Tove Fall, PhD Department of Medical Sciences Molecular Epidemiology and Science for Life Laboratory, Uppsala University Uppsala, Sweden

Dr. Tove Fall

Tove Fall, PhD
Department of Medical Sciences
Molecular Epidemiology and Science for Life Laboratory, Uppsala University
Uppsala, Sweden

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Type 1 diabetes is a severe chronic disease in children. There are few established risk factors, but it has been hypothesized that factors related to reduction of microbial exposure in childhood may increase the risk. We have previously shown that children in dog-owning families are at lower risk for asthma, and we now wanted to investigate the relationship of dog ownership and diabetes. We did this by studying the whole Swedish child population with record linkage across registers of health and dog ownership. We could not find evidence for an association of dog ownership and type 1 diabetes in the general population.

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Frequency of Retinal Screening in Diabetes May Be Tailored to Individual

MedicalResearch.com Interview with:
John M. Lachin, Sc.D.
Research Professor of Biostatistics and of Epidemiology, and of Statistics
The George Washington University Biostatistics Center and
David Matthew Nathan, M.D.
Professor of Medicine, Diabetes Unit
Massachusetts General Hospital 

MedicalResearch.com: What is the background for this study?

Response: Traditional guidelines for screening for retinopathy, based on indirect evidence, call for annual examinations. The automatic annual screening for retinopathy, without considering potential risk factors for progression,  appears excessive based on the slow rate of progression through sub-clinical states of retinopathy.

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Fresh Fruit Consumption May Lower Risk of Diabetes and Vascular Complications

MedicalResearch.com Interview with:
Huaidong Du

Senior Research Fellow
China Kadoorie Biobank
Medical Research Council Population Health Research Unit
Clinical Trial Service Unit & Epidemiological Studies Unit
Nuffield Department of Population Health
Oxford UK

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: This research article describes findings from the China Kadoorie Biobank study which is a large population based prospective cohort study including about 0.5 million adults recruited from 10 areas in China.

The main reason for us to perform this study is because previous evidence on potential benefit of fruit consumption in diabetes prevention and management is very limited. The sugar content of fruit has led to concerns in many parts of the world (e.g. China and several other Asian countries) about its potential harm for people with (high risk of) diabetes. This has consequently Chinese people diagnosed with diabetes tend to restrict their fruit intake. With the rapid increase of diabetes incidence in China and many other Asian countries, it is critically important to investigate the associations of fruit consumption with the incidence diabetes and, among those with diabetes already, diabetic macro- and microvascular complications.

Through analysing data collected during 7 years of follow-up, the study found that people who eat fresh fruit more frequently are at lower risk of developing diabetes and diabetes related vascular complications. Compared with non-consumers, those who ate fresh fruit daily had a 12% lower risk of developing diabetes. Among participants with diabetes at the start of the study, higher fresh fruit consumption also showed health benefits, with a 100g portion of fruit per day associated with 17% lower overall mortality, 13% lower risk of developing diabetes-related complications affecting large blood vessels (e.g. ischaemic heart disease and stroke) and 28% lower risk of developing complications affecting small blood vessels (e.g. kidney and eye diseases).

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Vascular Safety of Ranibizumab in Patients With Diabetic Macular Edema

MedicalResearch.com Interview with:

Marco A Zarbin, MD, PhD, FACS Alfonse Cinotti, MD/Lions Eye Research Professor and Chair Institute of Ophthalmology & Visual Science Rutgers-New Jersey Medical School Rutgers University Newark, NJ 0710

Dr. Zarbin

Marco A Zarbin, MD, PhD, FACS
Alfonse Cinotti, MD/Lions Eye Research
Professor and Chair
Institute of Ophthalmology & Visual Science
Rutgers-New Jersey Medical School
Rutgers University Newark, NJ 0710 

MedicalResearch.com: What is the background for this study? What are the main findings?

  1. Most large, randomized clinical trials are powered to assess the efficacy of drugs or interventions, but they usually do not enroll enough patients to accurately assess the frequency of uncommon, undesirable side effects.
  2. In order to compensate for this deficiency in trial design, investigators aggregate the results of numerous studies all of which address the same clinical question with the same (or similar) drugs/interventions to increase the power to detect uncommon side effects. These aggregate studies can be meta-analyses.
  3. Unfortunately, most meta-analyses do not have the ability to answer some critical questions such as the timing of an adverse event relative to the last exposure to the drug, nor can they compensate fully for differences among the aggregated studies in trial design, length of patient follow-up, or presence pre-existing risk factors for the side effects in question.
  4. A pooled analysis of combined clinical trials using patient level data, however, allows a more in depth analysis of side effects than study level data, which are usually used for most published meta-analyses, because patient level data allow one to incorporate the per-patient duration of exposure to treatment, adjust for imbalances in predefined baseline risk factors, and adjust for the effect of results of single studies on the overall result.

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Mortality From Cardiovascular Disease in Type 1 and Type 2 Diabetes Drops, But Still Exceeds General Population

MedicalResearch.com Interview with:

Aidin Rawshani, MD, PhD student Sahlgrenska Academy University of Gothenburg

Dr. Rawshani

Aidin Rawshani, MD, PhD student
Sahlgrenska Academy
University of Gothenburg

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Management of diabetes has improved in the past decades, studies have shown that mortality and cardiovascular disease among patients with diabetes has decreased, but these studies have not compared the trends among persons with type 1 diabetes and type 2 diabetes to those of the general population, where there have also been reductions in cardiovascular morbidity and mortality.

We observed marked reductions in incidence for cardiovascular disease and mortality among individuals with diabetes, however, similar trends were observed for the general population. We observed a 43% (HR 1.43, 95% CI 1.25–1.62) greater event rate reduction for cardiovascular disease among individuals with type 1 diabetes compared to matched controls. The reduction in the rate of fatal outcomes did not differ significantly between patients with type 1 diabetes and controls, whereas patients with type 2 diabetes had a 13% (HR 0.87, 95% CI 0.85–0.89) lesser event rate reduction compared with matched controls.

There was a 27% (HR 1.27, 95% CI 1.22–1.32) greater event rate reduction for cardiovascular disease among individuals with type 2 diabetes, compared with matched controls. Nevertheless, there remains a substantial excess overall rate of all outcomes analysed among persons with type 1 diabetes and type 2 diabetes, as compared with the general population.

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One Drop | Mobile APP Leads To Improved A1c in Diabetes

MedicalResearch.com Interview with:
Chandra Y. Osborn, PhD, MPH
VP, Health & Behavioral Informatics
One Drop
Informed Data Systems, Inc.

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: There are over 1,500 mobile apps for people with diabetes, but minimal evidence on their benefit. The One Drop | Mobile app launched in April 2015. Users manually and automatically track their blood glucose and self-care activities via One Drop’s | Chrome glucose meter, other Bluetooth-enabled meters, CGMs or other health apps. Users leverage One Drop’s food library, medication scheduler, automatic activity tracking, educational content, recipes, health tips, user polls, and peer support (‘likes’, stickers, and data sharing), and can set blood glucose, medication, carbohydrate intake, and activity goals, receive data-driven insights to draw connections between their behaviors, goals, and blood glucose readings. They can also self-report and track their hemoglobin A1c (A1c) and weight.

In July 2016, we queried data on ~50,000 people using One Drop | Mobile. In March 2017, we queried data on >160,000 users. Only users who had entered an A1c value when they started using the app, and entered a second A1c at least 60 days apart, but no more than 365 days apart, were included. In July 2016, people with diabetes using One Drop | Mobile reported a nearly 0.7% reduction in A1c during 2-12 months of using One Drop. In March 2017, users reported a 1.0% reduction in A1c for the same timeframe. A more recent diabetes diagnosis and using One Drop to track self-care activities was associated with more A1c improvement.

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Diabetic Retinopathy: OCTA May Improve Staging, Diagnosis and Monitoring

MedicalResearch.com Interview with:

José Cunha-Vaz, M.D., Ph.D. Emeritus Professor of Ophthalmology University of Coimbra, Portugal President of AIBILI Association for Innovation and Biomedical Research on Light and Image Editor-in-Chief of Ophthalmic Research Coordinator, Diabetic Retinopathy and Retinal Vascular Diseases, European Vision Institute Clinical Research Network (EVICR.net)

Dr. Cunha-Vaz

José Cunha-Vaz, M.D., Ph.D.
Emeritus Professor of Ophthalmology
University of Coimbra, Portugal
President of AIBILI
Association for Innovation and Biomedical Research on Light and Image
Editor-in-Chief of Ophthalmic Research
Coordinator, Diabetic Retinopathy and Retinal Vascular Diseases,
European Vision Institute Clinical Research Network (EVICR.net) 

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: In this study, we evaluated the clinical utility of quantitative measures of microvasculature in optical coherence tomographic angiography (OCTA). Although several studies have demonstrated the potential value of measures of microvasculature in the management of diabetic retinopathy (DR), our study uses the ROC curve to compare the overall value of different approaches. In this age matched population with a range of disease, the mean vessel density measured in the SRL had the highest AUC, indicating that it is best among the methods tested at differentiating normal eyes from eyes with diabetic retinopathy.

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Older Women Face Greater Risk of Diabetes From Statins

MedicalResearch.com Interview with:
Dr Mark Jones, Senior Lecturer
Faculty of Medicine and Biomedical Sciences, School of Public Health
The University of Queensland

MedicalResearch.com: What is the background for this study?

Response: Multiple clinical trials have shown statins reduce LDL cholesterol, cardiovascular events, and all-cause mortality. However statins are also associated with adverse events, including type 2 diabetes. There have been very few older women included in statin trials hence effects of the drug in this population are somewhat uncertain. Also, more generally, results from clinical trials may not translate well into clinical practice.

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Acute Kidney Injury Is A Frequent Complication of Pediatric Diabetic Ketoacidosis

MedicalResearch.com Interview with:

Constadina Panagiotopoulos, MD, FRCPC Department of Pediatrics, Endocrinology & Diabetes Unit British Columbia Children’s Hospital Vancouver, British Columbia, Canada

Dr. Panagiotopoulos

Constadina Panagiotopoulos, MD, FRCPC
Department of Pediatrics, Endocrinology & Diabetes Unit
British Columbia Children’s Hospital
Vancouver, British Columbia, Canada

MedicalResearch.com: What is the background for this study?

Response: I decided to conduct this study after observing a few cases of severe acute kidney injury (AKI) in children hospitalized with diabetic ketoacidosis (DKA) (with two patients requiring dialysis) while on call in the 18 months prior to initiating the study. While caring for these patients, I scanned the literature and realized that aside from 2 published case reports, there had been no large-scale systematic studies assessing AKI in children with DKA. It immediately became apparent to me that managing patients with AKI and DKA was more challenging. On presentation to hospital, many of these children with DKA present quite volume depleted but fluid management is conservative because of the risk for cerebral edema.

One of the most important management strategies for acute kidney injury in patients with DKA is early detection and correcting volume depletion in a timely manner to prevent further injury. I discussed my observations and these clinical cases with pediatric nephrologist and co-investigator Dr. Cherry Mammen, a pediatric AKI expert, and he confirmed my initial literature review findings. Thus, we decided to conduct this study to better understand the scope of the problem and any associated risk factors.

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