Author Interviews, Diabetes, Weight Research / 15.09.2017

MedicalResearch.com Interview with: 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). (more…)
Abuse and Neglect, Artificial Sweeteners, Diabetes / 14.09.2017

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 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. (more…)
Author Interviews, Diabetes, Heart Disease, Pharmacology / 31.08.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Hepatitis - Liver Disease / 18.08.2017

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  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. (more…)
Author Interviews, Diabetes, Education, JAMA, Pediatrics / 16.08.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Lancet, Parkinson's / 08.08.2017

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. (more…)
Author Interviews, Diabetes, Stem Cells, Weight Research / 04.08.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, JAMA, Ophthalmology, UC Davis / 30.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Erectile Dysfunction / 21.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Endocrinology, Menopause / 20.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Technology / 13.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Cost of Health Care, Diabetes / 10.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Ophthalmology / 07.07.2017

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. (more…)
Author Interviews, Diabetes, JAMA, Pharmacology / 05.07.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes / 04.07.2017

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 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. (more…)
Abuse and Neglect, Boehringer Ingelheim, Diabetes, Endocrinology, Lipids / 22.06.2017

MedicalResearch.com Interview with: 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. (more…)
AstraZeneca, Author Interviews, Boehringer Ingelheim, Diabetes, Eli Lilly, J&J-Janssen, Lipids, Merck / 19.06.2017

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 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. (more…)
Author Interviews, Diabetes, Pediatrics / 13.06.2017

MedicalResearch.com Interview with: 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). (more…)
Author Interviews, Diabetes, Vegetarians, Weight Research / 12.06.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes / 10.06.2017

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 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. (more…)
Author Interviews, Diabetes, Kidney Disease, Transplantation / 30.05.2017

MedicalResearch.com Interview with: 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%)
(more…)
Author Interviews, Autism, Diabetes, McGill, Nature / 24.05.2017

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. (more…)
Author Interviews, CMAJ, Diabetes, OBGYNE / 15.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Diabetologia, Nutrition, Pediatrics / 07.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: 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. (more…)
Author Interviews, Diabetes, NEJM, Ophthalmology, Personalized Medicine / 20.04.2017

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. (more…)
Author Interviews, Diabetes, Nutrition, PLoS / 19.04.2017

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). (more…)
Author Interviews, Boehringer Ingelheim, Diabetes, JAMA, Ophthalmology / 13.04.2017

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  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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Author Interviews, Diabetes, Heart Disease, NEJM / 13.04.2017

MedicalResearch.com Interview with: 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. (more…)