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%)
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.
Author Interviews, CMAJ, Diabetes, OBGYNE / 15.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34593" align="alignleft" width="200"]Dr. Gillian Booth PhD Researcher at St. Michael's and the Institute for Clinical Evaluative Sciences (ICES) Dr.Gillian Booth[/caption] 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.
Author Interviews, Diabetes, Diabetologia, Nutrition, Pediatrics / 07.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34452" align="alignleft" width="150"]Sari Niinistö, PhD Senior Researcher, Public Health Solutions, Nutrition Unit National Institute for Health and Welfare Helsinki, Finland Dr. Niinistö[/caption] 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.
Author Interviews, Diabetes, Pediatrics / 03.05.2017

MedicalResearch.com Interview with: [caption id="attachment_34375" align="alignleft" width="200"]Tove Fall, PhD Department of Medical Sciences Molecular Epidemiology and Science for Life Laboratory, Uppsala University Uppsala, Sweden Dr. Tove Fall[/caption] 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.
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.
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).
Author Interviews, Boehringer Ingelheim, Diabetes, JAMA, Ophthalmology / 13.04.2017

MedicalResearch.com Interview with: [caption id="attachment_33673" align="alignleft" width="170"]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[/caption] 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.
Author Interviews, Diabetes, Heart Disease, NEJM / 13.04.2017

MedicalResearch.com Interview with: [caption id="attachment_33866" align="alignleft" width="141"]Aidin Rawshani, MD, PhD student Sahlgrenska Academy University of Gothenburg Dr. Rawshani[/caption] 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.
Author Interviews, Diabetes, Technology / 04.04.2017

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.
Abuse and Neglect, Author Interviews, Diabetes, JAMA, Ophthalmology, Technology / 21.03.2017

MedicalResearch.com Interview with: [caption id="attachment_33226" align="alignleft" width="133"]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[/caption] 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.
Author Interviews, Diabetes, Gender Differences, Lipids / 16.03.2017

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.
Author Interviews, Diabetes, Kidney Disease, Pediatrics / 16.03.2017

MedicalResearch.com Interview with: [caption id="attachment_33007" align="alignleft" width="139"]Constadina Panagiotopoulos, MD, FRCPC Department of Pediatrics, Endocrinology & Diabetes Unit British Columbia Children’s Hospital Vancouver, British Columbia, Canada Dr. Panagiotopoulos[/caption] 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.
Author Interviews, Cost of Health Care, Diabetes / 07.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32757" align="alignleft" width="118"]Maria L. Alva, DPhil Public Health Economics Program RTI International 701 13 Street, NW, Suite 750 Washington, DC 20005 Dr. Maria Alva[/caption] Maria L. Alva, DPhil Public Health Economics Program RTI International 701 13 Street, NW, Suite 750 Washington, DC 20005  MedicalResearch.com: What is the background for this study? What are the main findings? Response:  Diabetes affects more than 25 percent of Americans over 65. The estimated economic cost of diagnosed diabetes is $245 billion a year. In spite of this we have almost no evidence of the impact of programs geared to stave off the cost of diabetes. The Y-USA received a Health Care Innovation Award of $11.8 million from the Centers for Medicare & Medicaid Services to offer a diabetes prevention program to individuals 65 and over with prediabetes. The goal of the Y-USA model is to get participants to lose 5 percent or more of their body weight and gradually increase their physical activity to 150 minutes per week.  The program lasts a year. The curriculum comprises sixteen weekly core sessions about healthy eating, exercise and motivation followed by eight monthly maintenance sessions. Epidemiological data from other studies have shown that the risk of diabetes increases with increased levels of BMI. There is mounting evidence that it is possible to prevent or delay diabetes through life-style intervention. It is unclear, however, whether weight-loss interventions can yield reductions in medical spending. The objective of our analysis was to establish whether the -USA Diabetes Prevention Program reduces health care spending and utilization among fee-for-service Medicare beneficiaries.
AACR, Author Interviews, Diabetes, Genetic Research, Melanoma / 01.03.2017

MedicalResearch.com Interview with: [caption id="attachment_32560" align="alignleft" width="200"]Reeti Behera, Ph.D. Postdoctoral fellow in the Weeraratna lab The Wistar Institute Philadelphia PA Dr. Behera[/caption] Reeti Behera, Ph.D. Postdoctoral fellow in the Weeraratna lab The Wistar Institute Philadelphia PA MedicalResearch.com: What is the background for this study? What are the main findings? Response: Malignant melanoma is an aggressive disease and is the cause of the majority of skin cancer deaths. In particular, older individuals have a much poorer prognosis for melanoma and are more resistant to targeted therapy than compared to young individuals. A recently published study from our lab has shown that age-related changes in secreted factors in the microenvironment can drive melanoma progression and therapy resistance. Klotho is a protein whose expression levels decreases with aging. In this study, we have shown that a decrease in klotho levels in the aged microenvironment drives melanoma aggression and therapy resistance by promoting the oncogenic signaling pathway Wnt5A. We also have shown that reconstituting klotho levels in the aged microenvironment by using rosiglitazone, an FDA-approved drug used to treat diabetes, can reduce tumor burden in aged mice. We also show that Klotho expression is decreased in therapy-resistant melanoma tumors. Reconstituting klotho levels in therapy-resistant melanoma cells by treating with rosiglitazone can inhibit Wnt5A levels and MAPK pathway. We also show that rosiglitazone can significantly decrease therapy-resistant tumor burden in the aged mice, but not in the young.
Author Interviews, Diabetes, JAMA, Pediatrics / 28.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32404" align="alignleft" width="140"]Dana Dabelea, MD, PhD Conrad M. Riley Professor of Epidemiology and Pediatrics Director, Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center University of Colorado Anschutz Medical Campus Aurora, CO 80045 Dr. Dana Dabelea[/caption] Dana Dabelea, MD, PhD Conrad M. Riley Professor of Epidemiology and Pediatrics Director, Lifecourse Epidemiology of Adiposity and Diabetes (LEAD) Center University of Colorado Anschutz Medical Campus Aurora, CO 80045 MedicalResearch.com: What is the background for this study? Response: These recent increasing trends in type 1 and 2 diabetes diagnosed in young individuals raise the question of whether the pattern of complications differs by diabetes type at similar ages and diabetes duration. The SEARCH for Diabetes in Youth Stud, looked at five health complications and co-morbidities of diabetes, including: retinopathy, diabetic kidney disease, peripheral, arterial stiffness and high blood pressure. The researchers studied 1,746 adolescents and young adults with type 1 diabetes and 272 with type 2 diabetes diagnosed when < 20 years, with a similar average duration of 7.9 years and at a similar age of 21 years.
Author Interviews, Diabetes, Metabolic Syndrome, Weight Research / 21.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32269" align="alignleft" width="142"]Prof. Dr. Michael Roden Director, German Diabetes Center (DDZ) Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf Chair/Professor, Endocrinology and Metabolic Diseases Heinrich Heine University Düsseldorf Director, Department of Endocrinology and Diabetology University Hospital Düsseldorf Düsseldorf, Germany Prof. Michael Roden[/caption] Prof. Dr. Michael Roden Director, German Diabetes Center (DDZ) Leibniz Center for Diabetes Research at Heinrich Heine University Düsseldorf Chair/Professor, Endocrinology and Metabolic Diseases Heinrich Heine University Düsseldorf Director, Department of Endocrinology and Diabetology University Hospital Düsseldorf Düsseldorf, Germany MedicalResearch.com: What is the background for this study? What are the main findings? Response: The prevalence of obesity, type 2 diabetes and non-alcoholic fatty liver disease (NAFLD) continue to increase at an alarming rate. Their occurrence has been associated with intake of saturated fats, for example that of palm oil. This study aimed to shed light on how dietary fat initiates metabolic changes which lead to the aforementioned diseases. To this end we provided 14 young healthy volunteers an oral dose of palm oil or placebo randomly, in a crossover manner, with an 8-week washout period between each intervention. One acute dose of palm oil leads to insulin resistance in the main insulin sensitive tissues of the body: the liver, skeletal muscle and adipose tissue. In the liver, it also results in increased accumulation of triglycerides, increased production of glucose from lipid and amino acid precursors (rather than from glycogen), and increased energy metabolism, as denoted by increased hepatic adenosine triphosphate (ATP) content. Moreover, a similar experiment in mice revealed that one dose of palm oil differentially regulates genes and pathways which are known or suspected regulators of NAFLD, such as lipopolysaccharide (LPS), members of the peroxisome proliferator-activated receptor (PPAR) family and nuclear factor kappa-light-chain-enhancer of activated B-cells.
Author Interviews, Diabetes, OBGYNE / 18.02.2017

MedicalResearch.com Interview with: [caption id="attachment_32182" align="alignleft" width="166"]Dr Sophie Jacqueminet Praticien Hospitalier Service de Diabétologie Pole Cardio Métabolisme Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix Dr Sophie Jacqueminet[/caption] Dr Sophie Jacqueminet Praticien Hospitalier Service de Diabétologie Pole Cardio Métabolisme Hôpitaux Universitaires Pitié Salpêtrière - Charles Foix MedicalResearch.com: What is the background for this study? What are the main findings? Response: The proportion of women who are overweight or obese is increasing in almost all countries worldwide, and this is being accompanied by an increased risk of developing both type 2 diabetes (T2D) (whether pregnant or not) and gestational diabetes (GDM). While other studies have analysed the links between GDM and adverse outcomes in babies, very large studies that draw on an entire national database, study, are rare. In our research, all 796,346 deliveries taking place after 22 weeks in France in 2012 were included by extracting data from the hospital discharge database and the national health insurance system. Outcomes were analysed according to the type of diabetes and, in the GDM group, whether or not diabetes was insulin-treated. The cohort of 796,346 deliveries involved 57,629 (7.24%) mothers with gestational diabetes mellitus. Data linking the mother to the child were available for 705,198 deliveries (88% of the total). The risks of adverse outcomes were two to four times higher for babies of mothers with type 2 diabetes before pregnancy (pregestational diabetes) than for those with GDM. We then adjusted our data, limiting the analysis to deliveries after 28 weeks to ensure all women diagnosed with GDM were included (since diagnosis of GDM in most cases takes place at or after 28 weeks). Following adjustment, the increased risk of various complications for mothers with gestational diabetes versus mothers without GDM were: preterm birth 30%; Caesarean section 40%; pre-eclampsia/eclampsia 70%; babies born significantly larger than average size (macrosomia) 80%; respiratory distress 10%; birth trauma 30%; and cardiac malformations 30%. While these increased risks combine women with both insulin- and diet-treated GDM, most of the increased risk is found in women with insulin-treated GDM. This is because as stated above, the diabetes is more serious and blood sugar more difficult to control in women who need insulin treatment, resulting in a higher risk of complications than in those women treated with diet only.