Author Interviews, Depression, Diabetes, JAMA, Pediatrics, Pharmacology / 17.10.2017

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.
Author Interviews, Diabetes, Heart Disease, JAMA, OBGYNE / 17.10.2017

MedicalResearch.com Interview with: [caption id="attachment_35407" align="alignleft" width="125"]Cuilin Zhang MD, PhD Senior Investigator, Epidemiology Branch Division of Intramural Population Health Research NICHD/National Institutes of Health Bethesda, MD 20817  Dr. Zhang[/caption] 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.
Author Interviews, Diabetes, Nature / 04.10.2017

MedicalResearch.com Interview with: [caption id="attachment_37356" align="alignleft" width="165"]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[/caption] 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.
Author Interviews, Diabetes, Gastrointestinal Disease, Lancet, Mayo Clinic, Weight Research / 29.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37242" align="alignleft" width="125"]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[/caption] 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.
Author Interviews, Diabetes, NEJM, Surgical Research, Weight Research / 20.09.2017

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.
Author Interviews, Diabetes, Geriatrics, Primary Care / 19.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37029" align="alignleft" width="117"]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[/caption] 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.
Author Interviews, Diabetes, Flu - Influenza, Genetic Research / 19.09.2017

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.
Author Interviews, Compliance, Diabetes / 15.09.2017

MedicalResearch.com Interview with: [caption id="attachment_37002" align="alignleft" width="100"]Alexander Turchin, MD, MS Director of Quality in  Diabetes in the Division of Endocrinology, Diabetes and Hypertension Brigham and Women's Hospital Dr. Turchin[/caption] 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.
Author Interviews, Diabetes, Weight Research / 15.09.2017

MedicalResearch.com Interview with: [caption id="attachment_28464" align="alignleft" width="125"]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[/caption] 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).
Abuse and Neglect, Artificial Sweeteners, Diabetes / 14.09.2017

MedicalResearch.com Interview with: [caption id="attachment_36959" align="alignleft" width="100"]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[/caption] 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.
Author Interviews, Diabetes, Heart Disease, Pharmacology / 31.08.2017

MedicalResearch.com Interview with: [caption id="attachment_36706" align="alignleft" width="171"]Todd Hobbs, MD Vice President and Chief Medical Officer Novo Nordisk North America Dr. Hobbs[/caption] 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.
Author Interviews, Diabetes, Hepatitis - Liver Disease / 18.08.2017

MedicalResearch.com Interview with: [caption id="attachment_36529" align="alignleft" width="153"]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[/caption] 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.
Author Interviews, Diabetes, Education, JAMA, Pediatrics / 16.08.2017

MedicalResearch.com Interview with: [caption id="attachment_36476" align="alignleft" width="146"]Jane E. Harding, DPhil Liggins Institute The University of Auckland Auckland, New Zealand Prof. Harding[/caption] 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.
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.
Author Interviews, Diabetes, Stem Cells, Weight Research / 04.08.2017

MedicalResearch.com Interview with: [caption id="attachment_36314" align="alignleft" width="149"]Dr. Xiaoyang Wu PhD Ben May Department for Cancer Research The University of Chicago, Chicago, IL Dr. Xiaoyang Wu[/caption] 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.
Author Interviews, Diabetes, JAMA, Ophthalmology, UC Davis / 30.07.2017

MedicalResearch.com Interview with: [caption id="attachment_36127" align="alignleft" width="200"]Jeffrey R. Willis MD, PhD  Dr. Willis[/caption] 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.
Author Interviews, Diabetes, Erectile Dysfunction / 21.07.2017

MedicalResearch.com Interview with: [caption id="attachment_36076" align="alignleft" width="192"]Damiano Pizzol  Operational Research Unit, Doctors with Africa Cuamm Beira, Mozambique Damiano Pizzol [/caption] 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.
Author Interviews, Diabetes, Endocrinology, Menopause / 20.07.2017

MedicalResearch.com Interview with: [caption id="attachment_36029" align="alignleft" width="159"]Eralda Asllanaj Department of Epidemiology Erasmus University Medical Center Rotterdamthe Netherlands Eralda Asllanaj[/caption] 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.
Author Interviews, Diabetes, Technology / 13.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35893" align="alignleft" width="152"]David Moore MBA Senior Vice President of Marketing Novo Nordisk  David Moore[/caption] 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.
Author Interviews, Cost of Health Care, Diabetes / 10.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35816" align="alignleft" width="200"]Maria L. Alva, DPhil Economist RTI International -  Research Triangle Institute Dr. Alva[/caption] 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.
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.
Author Interviews, Diabetes, JAMA, Pharmacology / 05.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35738" align="alignleft" width="150"]Wendy Lane MD Director of Clinical Research Mountain Diabetes and Endocrine Center Asheville, NC  Dr. Lane[/caption] 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.
Author Interviews, Diabetes / 04.07.2017

MedicalResearch.com Interview with: [caption id="attachment_35675" align="alignleft" width="144"]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[/caption] 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.
Abuse and Neglect, Boehringer Ingelheim, Diabetes, Endocrinology, Lipids / 22.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35536" align="alignleft" width="131"]Dr-Robert-R-Henry.jpg Dr. Henry[/caption] 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.
AstraZeneca, Author Interviews, Boehringer Ingelheim, Diabetes, Eli Lilly, J&J-Janssen, Lipids, Merck / 19.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35424" align="alignleft" width="200"]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[/caption] 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.
Author Interviews, Diabetes, Pediatrics / 13.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35296" align="alignleft" width="142"]Prof. Dr. Thomas Danne Chief Physician Diabetology, Endocrinology and General Pediatrics and Clinical Researc Kinder und Junden Krankenhau Prof. Danne[/caption] 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).
Author Interviews, Diabetes, Vegetarians, Weight Research / 12.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35233" align="alignleft" width="200"]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[/caption] 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.
Author Interviews, Diabetes / 10.06.2017

MedicalResearch.com Interview with: [caption id="attachment_35200" align="alignleft" width="150"]Katrina Donahue MD, MPH Professor, Director of Research, UNC Family Medicine. Co-Director,  North Carolina Newtork Consortium (NCNC). Chapel Hill, NC Dr. Donahue[/caption] 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.
Author Interviews, Diabetes, Kidney Disease, Transplantation / 30.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34998" align="alignleft" width="151"]Deborah Evans, MA, MSW, LCSW Manager, Social Work Services DaVita Kidney Care Deborah Evans[/caption] 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%)