Decreased Risk of Diabetes With Diet Emphasizing Plant-Based Foods

MedicalResearch.com Interview with:

Frank Qian, MPH Department of Nutrition Harvard T. H. Chan School of Public Health Boston, Massachusetts

Frank Qian

Frank Qian, MPH
Department of Nutrition
Harvard T. H. Chan School of Public Health
Boston, Massachusetts

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

Response: Plant-based diets have really grown in popularity in the last several years, particularly among the younger generation in the United States, many of whom are adopting a plant-based or vegetarian/vegan diet. However, the quality of such a diet can vary drastically. While many prior studies have demonstrated beneficial associations for risk of type 2 diabetes with healthful plant-based foods such as fruits, vegetables, nuts/seeds, whole grains, and legumes, the opposite is true for less healthful plant-based foods such as potatoes and refined grains such as white rice. In addition, some animal-based foods, such as dairy and fish, have shown protective associations against the development of type 2 diabetes, so strict vegetarian diets which exclude these foods may miss out on the potential benefits.

Given these divergent findings, we sought to pool all the available data from prior cohort studies to analyze whether the overall association of a diet which emphasizes plant-based foods (both healthful and unhealthful) are related to risk of type 2 diabetes.

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Type 1 Diabetes in Children Alters Brain Growth and Function

MedicalResearch.com Interview with:

Nelly Mauras, MD Chief, Division of Pediatric Endocrinology, Nemours Children’s Health System Professor of Pediatrics Mayo College of Medicine

Dr. Mauras

Nelly Mauras, MD
Chief, Division of Pediatric Endocrinology,
Nemours Children’s Health System
Professor of Pediatrics
Mayo College of Medicine

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

Response: Keeping blood sugars close to normal in young children with diabetes is often limited by parental fears of the risks of low blood sugars and impaired cognitive development. Dr. Nelly Mauras, at the Nemours Children’s Health System in Jacksonville FL, along with Dr. Allan Reiss at Stanford University are co-principal investigators of the Diabetes Research in Children Network, a 5-center consortium performing studies in children with diabetes, also including the University of Iowa, Washington University St Louis and Yale University.

The investigators recruited 144 children with type 1 diabetes who were 4-7 years old and performed brain imaging (MRIs), did special cognitive tests, and monitored blood sugars using continuous glucose monitors. These studies were repeated after 18 months, approximately 54 months and 74 months, to examine changes in the brain and compare the results with those of 70 children the same age who do not have diabetes.

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What Accounts for Increase in National Spending on Antidiabetic Drugs?

MedicalResearch.com Interview with:
Xiaohui Zhuo, PhD
Division of Diabetes Translation
National Center for Chronic Disease Prevention and Health Promotion
Centers for Disease Control and Prevention,
Atlanta, GA 

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

Response: Prescription drug spending (spending from families and individuals, their medical providers (doctors, hospitals, pharmacies, etc.) and employees across the United States) has increased at a much higher rater than other components of the total medical expenditure associated with diabetes.  The share of spending on prescription drugs in per capita annual excess expenditure due to diabetes increased from 27% to 41% between 1987 and 2011, according to a previous study using national data from the Agency for Healthcare Research and Quality Medical Expenditures Panel Surveys.

In this most recent study, CDC researchers estimated the increase in the national spending on antidiabetic drugs from 2005 to 2016 in total and by drug class and broke down the increase in total national spending by examining what factors have contributed to the increase estimating the magnitude of each factor’s contribution.

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Statins May Double Risk of Diabetes

MedicalResearch.com Interview with:

Victoria A. Zigmont, PhD MPH Southern Connecticut State University/ Department of Public Health Assistant Professor New Haven, CT

Dr. Zigmont

Victoria A. Zigmont, PhD MPH
Southern Connecticut State University
Department of Public Health
Assistant Professor
New Haven, CT

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

  • We were interested in conducting this study to better understand the diabetogenic risks (dysglycemia (measured using elevated HbA1c) and new diagnoses of diabetes) associated with statin use for everyday people in the general population.
  • We conducted a retrospective cohort study and compared new users of statins to equivalent nonusers of statins. All of the study participants had indications for statin use in their electronic medical records for the primary (patients without a history of cardiovascular disease (CVD)) or secondary prevention (patients who have had CVD) of CVD. This study used pharmacy and medical claims, and biometric data as well as data from a health survey.

MedicalResearch.com: What are the main findings?

Response: After adjusting for confounding factors (age, gender, education level, ethnicity, cholesterol and triglyceride readings, body mass index, waist circumference and the number of visits to the doctor) statin users had at least double the risk for developing type 2 diabetes mellitus compared to statin nonusers. Individuals who used statins for the longest period of time (more than 2 years) had an even greater risk (3 times greater) for developing type 2 diabetes mellitus, after adjusting for confounding factors.

MedicalResearch.com: What should readers take away from your report?

  • These study findings indicate that statin users should receive special guidance on diet and physical activity for diabetes prevention from their medical care team. These individuals should also receive close monitoring to detect changes in glucose metabolism.
  • Statins are a well-established way to prevent heart attacks and strokes. It could be harmful if patients stopped taking their statins, and they should talk to their physicians if they have concerns about side effects associated with their medications.

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

Response: Further research is needed to understand which statins and doses lead to a greater risk of diabetes, and well as the impact of statins on human metabolism. Clinical studies testing new medications should report on the risks and benefits in addition to the desired clinical outcomes.

This study was conducted as part of my doctoral dissertation at the Ohio State University. I am now an assistant professor at Southern Connecticut State University (New Haven). The study co-authors were Drs. Susan Olivo-Marston (dissertation advisor), Abigail Shoben, Bo Lu, Steven Clinton, Randall Harris and Gail Kaye. 

Citation:

Victoria A. Zigmont, Abigail B. Shoben, Bo Lu, Gail L. Kaye, Steven K. Clinton, Randall E. Harris, Susan E. Olivo‐Marston. Statin users have an elevated risk of dysglycemia and new‐onset‐diabetes. Diabetes/Metabolism Research and Reviews, 2019; e3189 DOI: 1002/dmrr.3189

 

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The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

FARXIGA (dapagliflozin) Reduced Kidney Function Decline in Type II Diabetes

MedicalResearch.com Interview with:

Naeem Khan MD Vice President at AstraZeneca

Dr. Khan

Naeem Khan MD
Vice President at AstraZeneca 

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

Response: A pre-specified exploratory analysis of renal data from the DECLARE-TIMI 58 trial, the largest SGLT-2 inhibitor (SGLT-2i) cardiovascular outcomes trial (CVOT) conducted to date, showed that FARXIGA (dapagliflozin) reduced the composite of kidney function decline, end-stage renal disease (ESRD) or renal death by 47% in patients with type 2 diabetes (T2D).

Additionally, FARXIGA reduced the relative risk of a cardio-renal composite of kidney function decline, ESRD, or renal or cardiovascular (CV) death by 24% compared to placebo.

The analysis evaluated 17,160 patients with type 2 diabetes and predominantly preserved renal function, irrespective of underlying atherosclerotic CV disease (ASCVD).

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Type 2 Diabetes More Aggressive in Youth

MedicalResearch.com Interview with:
Dr. Ellen Leschek MD
Program Director: Division of Diabetes, Endocrinology, and Metabolic Diseases
The National Institute of Diabetes and Digestive and Kidney Diseases
Health Information Center

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

Response: Type 2 diabetes (T2D) is thought to be characterized by a progressive loss of pancreatic beta cell (insulin producing/releasing cell) function. For this reason, T2D medications eventually stop working and individuals with T2D require treatment with insulin.

The Restoring Insulin Secretion (RISE) Consortium was established by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to evaluate the effects of treatment and treatment withdrawal on the loss of pancreatic beta cell function. In the RISE Study, progression of disease was assessed by the measurement of pancreatic beta cell function in youth and adults who had either impaired glucose tolerance (IGT; prediabetes) or recently diagnosed Type 2 diabetes before, during and after treatment with study medications. Importantly, the RISE Pediatric Medication Study and the RISE Adult Medication Study were designed in tandem to allow direct comparison of the effects of two pharmacologic treatment regimens (the only two FDA-approved medications for Type 2 diabetes in youth) on disease progression in youth and adults. For more information about the RISE Study, please visit https://rise.bsc.gwu.edu/web/rise.

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Insulin Costs Rise But Mostly Not Paid For Out-of-Pocket by Patients

MedicalResearch.com Interview with:
Dr. Hui ShaoDr. Hui Shao, MBBS, MHA, PhD
CDC

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

Response: 23.1 million people in the U.S. have diagnosed diabetes and 7.4 million regularly use one or more types of insulin. Spending on insulin accounts for a large portion of the costs associated with diabetes. Affordability of insulin has become a public health concern in recent years as high spending on insulin imposes a large financial burden on the national health care system and is associated with poor adherence and health outcomes.

MedicalResearch.com: What are the main findings?

Response: In this study, we analyzed the recent trends in usage and total payments, and patients’ out-of-pocket (OOP) payments for insulin by type in privately insured Americans (MarketScan Claims database) 2003-2017.  We estimated total payment and out-of-pocket payment for a 30-day/yearly supply of different types of insulin and found that, on average, inflation-adjusted annual total payments for insulin increased yearly by around 6% ($153) between 2003 and 2012 and by around 13% ($592) between 2011 and 2017. Similar increase patterns were observed across insulin types.

The major driver for increases in average total payments for a 30-day supply of insulin were explained by increases in payments for existing products and not by changes in the market share of insulin types. In contrast, out-of-pocket payments increased only marginally, suggesting that the increase in insulin spending was not paid directly by the patient.

MedicalResearch.com: What should readers take away from your report?

Response: The average annual total payment increased substantially during the study period, from $1,982 per year in 2003 to $6,360 per year in 2017 (in inflation-adjusted in 2017$). Total payments for insulin have been increasing since 2003 but were at much higher rates after 2011. In contrast, annual out-of-pocket costs increased only marginally from $390 to $451 during the same period, suggesting that the sharp payment increases were not paid out of pocket by the patient. The payment increase occurred across all insulin types, suggesting a lack of inexpensive alternatives in the insulin market. Even for human insulin, the cheapest form of insulin, the average payment for a 30-day supply caught up with insulin analogs in 2017.                                               

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

Response: Our study population is those with private insurance with the fee for service. Additional research is needed to help determine if similar spending patterns are observed in persons with other types of health insurance, especially those with high-deductible plans and those without health insurance.

Further research in this area could also help us determine the cause of rising insulin costs, and inform decision-making at all levels, which could reduce insulin cost, or slow the consistent increase in cost. 

MedicalResearch.com: Is there anything else you would like to add?

Response: There are no additional comments or disclosures. For more information about how the CDC works to prevent and control diabetes visit https://www.cdc.gov/diabetes/index.html.

 Citation: ADA 2019 abstract

Trend in Total Payment and Out-of-Pocket Payment on a Yearly Supply of Oral Antidiabetic Drug Types among U.S. Adults with Private Health Insurance from 2003 to 2016

HUI SHAOMICHAEL LAXYSTEPHEN R. BENOITYILING J. CHENGEDWARD GREGG and PING ZHANG

 

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The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

 

Islet Cell Transplantation Can Give Some Diabetics Long Term Glucose Control

MedicalResearch.com Interview with:

Dr. Rodolfo Alejandro, MD Professor of Medicine University of Miami Miller School of Medicine Co-Director of the Cell Transplant Center Director/Attending Physician of the Clinical Cell Transplant Program Diabetes Research Institute

Dr. Alejandro

Dr. Rodolfo Alejandro, MD
Professor of Medicine
University of Miami Miller School of Medicine
Co-Director of the Cell Transplant Center
Director/Attending Physician of the Clinical Cell Transplant Program
Diabetes Research Institute
www.DiabetesResearch.org 

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

Response: In type 1 diabetes, the insulin-producing islets cells of the pancreas have been mistakenly destroyed by the immune system, requiring patients to manage their blood sugar levels through a daily regimen of insulin therapy. Islet transplantation has allowed some patients to live without the need for insulin injections after receiving a transplant of donor cells. Some patients who have received islet transplants have been insulin independent for more than a decade, as DRI researchers have published. Currently, islet transplantation remains an experimental procedure limited to a select group of adult patients with type 1 diabetes.Although not all subjects remain insulin independent, like the subjects described in this presentation, after an islet transplant a significant number of them continue with excellent graft function for over 10 years that allows them to have near-normal glucose metabolism in the absence of severe hypoglycemia on small doses of insulin.

In 2016, the National Institutes of Health-sponsored Clinical Islet Transplantation Consortium reported results from its Food and Drug Administration (FDA)-authorized Phase 3 multi-center trial, of which the DRI was a part, indicating that islet transplantation was effective in preventing severe hypoglycemia (low blood sugar levels), a particularly feared complication in type 1 diabetes that can lead to seizures, loss of consciousness and even death.

The study was a significant step toward making islet transplantation an approved treatment for people with type 1 diabetes and reimbursable through health insurance, as it is in several other countries around the world.   Continue reading

Apple or Pear? Body Shape Not Determined Just by Fat

MedicalResearch.com Interview with:

MedicalResearch.com Interview with: Kalypso Karastergiou, MD, PhD Assistant Professor, Medicine, Endocrinology, Diabetes and Bone Disease Diabetes, Obesity and Metabolism Institute Icahn School of Medicine at Mount Sinai     MedicalResearch.com:  What is the background for this study?   Response: Multiple studies, epidemiological as well as clinical, have established that body shape is an important and independent predictor of cardiovascular and metabolic disease risk and ultimately total mortality. Subjects that preferentially store weight in the abdominal area (often described as android, upper-body or apple-shape obesity) are at increased risk, whereas those who preferentially store weight in the lower body, in the gluteofemoral area (gynoid, lower-body or pear-shape), appear to be protected. The former is more common in men, whereas the latter in women, especially premenopausal women.   The overarching questions in the field are:  •What factors determine body shape?  •	Why are subjects with lower-body shape protected?  •	Can we exploit the physiological and pathophysiological mechanisms involved to improve stratification, prevention or treatment of obesity and related diseases?   MedicalResearch.com: What are the main findings?   Response: Up to date, studies in body shape have focused on the distribution of the adipose (fat) tissue.  This report seeks to expand the investigation to other tissues as well. During the period from 1999-2006, 14,005 participants in the National Health and Nutrition Examination Survey (which represents the United States population), 20-69 years old, had a DXA test that allows total and regional estimation of fat, lean and bone tissue mass.   This preliminary analysis shows that body shape is determined by coordinated changes in the head, trunk and limbs that involve the fat, as well as the other tissues.     MedicalResearch.com: What should readers take away from your report?  Response: This is an observational study that doesn’t allow us to draw conclusion as to cause and effect or prediction of future risk. It does suggest that body shape is a whole-body feature with systematic, coordinated changes in all body compartments and tissues.   The observations should be replicated in other populations and in prospective studies.      MedicalResearch.com: What recommendations do you have for future research as a result of this work?  Response: This report generates more questions than it answers.   •	First of all, are there differences in the function of tissues that determine body shape between subjects with upper- versus lower body shape?   •	Which tissues drive differences in physiology and disease risk?   •	Can we identify the underlying molecular pathways?   •	Does any of these pathways represent a viable mechanistic target to prevent or treat disease and improve quality of life?     Dislosures The study is partly funded by grants from the MSHS Translational Science Hub at Icahn School of Medicine at Mount Sinai (KL2TR001435) and the Einstein-Sinai Diabetes Research Center in New York City.     Citation: ADA 2019 abstract  277-OR: Lean Tissues as Novel Determinants of Pear vs. Apple Body Shape and Metabolic Health in Humans KALYPSO KARASTERGIOU Diabetes 2019 Jun; 68(Supplement 1): -.https://doi.org/10.2337/db19-277-OR      [last-modified]    The information on MedicalResearch.com is provided for educational purposes only, and is in no way intended to diagnose, cure, or treat any medical or other condition. Always seek the advice of your physician or other qualified health and ask your doctor any questions you may have regarding a medical condition. In addition to all other limitations and disclaimers in this agreement, service provider and its third party providers disclaim any liability or loss in connection with the content provided on this website.

Dr. Karastergiou

Kalypso Karastergiou, MD, PhD
Assistant Professor, Medicine, Endocrinology, Diabetes and Bone Disease
Diabetes, Obesity and Metabolism Institute
Icahn School of Medicine at Mount Sinai 

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

Response: Multiple studies, epidemiological as well as clinical, have established that body shape is an important and independent predictor of cardiovascular and metabolic disease risk and ultimately total mortality. Subjects that preferentially store weight in the abdominal area (often described as android, upper-body or apple-shape obesity) are at increased risk, whereas those who preferentially store weight in the lower body, in the gluteofemoral area (gynoid, lower-body or pear-shape), appear to be protected. The former is more common in men, whereas the latter in women, especially premenopausal women.

The overarching questions in the field are:

  • What factors determine body shape?
  • Why are subjects with lower-body shape protected?
  • Can we exploit the physiological and pathophysiological mechanisms involved to improve stratification, prevention or treatment of obesity and related diseases? 

Continue reading

The Vitamin D and Type 2 Diabetes Study

MedicalResearch.com Interview with:

Anastassios G. Pittas, M.D MS Professor Co-Director, Diabetes and Lipid Center; Tufts University School of Medicine

Dr. Pittas

Anastassios G. Pittas, M.D MS
Professor
Co-Director, Diabetes and Lipid Center;
Tufts Medical Center

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

Response: Observational studies have consistently reported an association between low blood vitamin D level and development of type 2 diabetes. However, whether vitamin D supplementation lowers risk of developing diabetes is not known. We designed and conducted the Vitamin D and diabetes (D2d) study to answer this question.  We randomized 2,423 people with prediabetes to 4,000 IU/day of vitamin D3 or placebo and followed them for new-onset diabetes with blood tests every 6 months for an average of 2.5 years. About 80% of participants had sufficient vitamin D level at baseline (25-hydroxyvitamin D level >= 20 ng/mL). The trial was designed to show a reduction of 25% or more in diabetes risk with vitamin D.

The study was unable to show a reduction of 25% or more. At the end of the study, there was a 12% reduction in risk of developing diabetes with vitamin D, which missed statistical significance (hazard ration 0.88; 95% confidence interval 0.75 to 1.04). In a small subgroup of participants with vitamin D deficiency at baseline (25-hydroxyvitamin D level < 12 ng/mL) there was 62% reduction in risk of diabetes with vitamin D (hazard ration 0.38; 95% confidence interval 0.18 to 0.80).

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Midlife Type 2 Diabetes Mellitus Linked to Increased Risk of Ischemic Stroke

MedicalResearch.com Interview with:
Rongrong Yang, PhD candidate

Tianjin Medical University 

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

Response: Worldwide, cerebrovascular disease (CBD) and type 2 diabetes mellitus (T2DM) are common disorders that have become among the top ten leading causes of death, killing approximately 8 million people in 2016. Both T2DM and CBD are complex genetic and lifestyle-related disorders. Genetic and familial environmental factors (e.g. foetal environment, maternal smoking and childhood socioeconomic status) have been shown to be involved in the development of both conditions. Accumulating evidence from previous studies suggests that T2DM is independently associated with an increased risk of CBD, especially ischemic CBD.

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Teleretinal Imaging Improves Detection of Diabetic Retinopathy in Low Resource Setting

MedicalResearch.com Interview with:

Thulasiraj RavillaExecutive Director – LAICO &Director – OpeationsAravind Eye Care SystemTamilnadu, India 

Mr. Thulasiraj

Thulasiraj Ravilla
Executive Director – LAICO &
Director – Opeations
Aravind Eye Care System
Tamilnadu, India 

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

Response: Diabetic Retinopathy (DR) is a visual consequence of diabetes and various other studies have reported that in India, 10% to 30% of adults with diabetes have DR, with higher rates found in older people and urban areas. Undetected DR leads to vision loss and eventually blindness. Thus early identification of DR is critical to initiate appropriate treatment to reduce the rate of vision loss.

Conventional approaches of requesting diabetologists to refer patients with diabetes to an ophthalmologist has been ineffective due to compliance issues, both by the diabetologists and the patients. Similarly screening through outreach eye camps have not been found to be effective in India and other developing countries owing to inadequate eye care resources. Teleretinal screening for Diabetic Retinopathy is increasingly being used in India. Evidence from randomized clinical trials on the benefits of teleretinal screening is limited. Whatever evidence is there are from high income countries, which often have little relevance to developing countries.

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FDA Approves EYLEA (aflibercept) To Treat All Stages of Diabetic Retinopathy, With Two Dosing Options

MedicalResearch.com Interview with:

Blausen.com staff (2014). "Medical gallery of Blausen Medical 2014". WikiJournal of Medicine 1 (2). DOI:10.15347/wjm/2014.010. ISSN 2002-4436. Illustration depicting diabetic retinopathy

Illustration depicting diabetic retinopathy


Robert L. Vitti, MD, MBA
Vice President and Head, Ophthalmology
Regeneron Pharmaceuticals

Dr. Vitti discusses the recent announcement that the FDA has approved EYLEA to treat all stages of diabetic retinopathy.

MedicalResearch.com: Can you provide additional background on this approval? Would you briefly explain diabetic retinopathy and it’s impact on patients?

Response: The FDA has approved EYLEA (aflibercept) Injection to treat all stages of diabetic retinopathy (DR). DR is the leading cause of blindness among working-aged American adults. Approximately 8 million people live with DR, a complication of diabetes characterized by damage to the blood vessels in the retina (per 2010 data).

The disease generally starts as non-proliferative diabetic retinopathy (NPDR) and often has no warning signs or symptoms. Over time, NPDR often progresses to proliferative diabetic retinopathy (PDR), a stage in which abnormal blood vessels grow on the surface of the retina and into the vitreous cavity, potentially causing severe vision loss.

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Small Increased Risk of Diabetes with Common Drug for Prostate Enlargement

MedicalResearch.com Interview with:

Professor Ruth Andrew PhDChair of Pharmaceutical EndocrinologyUniversity/BHF Centre for Cardiovascular ScienceQueen's Medical Research InstituteUniversity of Edinburgh

Dr. Andrew

Professor Ruth Andrew PhD
Chair of Pharmaceutical Endocrinology
University/BHF Centre for Cardiovascular Science
Queen’s Medical Research Institute
University of Edinburgh 

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

Response: Our research group has been interested for a number of years in how stress hormones (called glucocorticoids) influence the risk of heart disease and diabetes. Glucocorticoids help us control stress and regulate how the body handles its fuel, for example the carbohydrate and fat we eat. However exposure to high levels of glucocorticoids, can increase the risk of diabetes, obesity and high blood pressure.

We studied men with prostate disease who took 5α-reductase inhibitors, because over and above the beneficial actions of these drugs in the prostate, they also slow down inactivation of glucocorticoids. We had carried out some short term studies with the drugs in humans and found that they reduced the ability of insulin to regulate blood glucose. Therefore in the study we have just published in the BMJ, we examined how patients receiving these drugs long-term responded and particularly we were able to show that over an 11 year period that there was a small additional risk of developing type 2 diabetes, the type of disease common in older people, compared with other types of treatments. Continue reading

Metformin More Effective For Weight Loss Maintenance Than Lifestyle Alone

MedicalResearch.com Interview with:
Kishore M. Gadde, MD, Professor
Fairfax Foster Bailey Endowed Chair in Heart Disease Prevention
Medical Director, Clinical Services
Pennington Biomedical Research Centre
Baton Rouge, LA 70808 

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

Response: Around 20 years ago, the Diabetes Prevention Program, DPP, enrolled 3,234 adults with excess body weight and impaired glucose tolerance. The idea was to compare the efficacy of either an intensive lifestyle intervention or metformin relative to placebo in preventing diabetes. Over approximately 3 years, both lifestyle and metformin were effective, but lifestyle intervention was better for weight loss as well as in reducing the risk of diabetes. After the blinded treatment phase ended, the researchers continued to follow this cohort in their originally randomised groups.  Continue reading

Most Diabetes Apps Do Not Provide Real Time Decision Support (yet)

MedicalResearch.com Interview with:

Associate Professor Josip CarMD, PhD, DIC, MSc, FFPH, FRCP (Edin)​Associate Professor of Health Services Outcomes Research,​Director, Health Services Outcomes Research Programme and DirectorCentre for Population Health SciencesPrincipal Investigator, Population Health & Living Laboratory

Prof. Car

Associate Professor Josip Car
MD, PhD, DIC, MSc, FFPH, FRCP (Edin)​
Associate Professor of Health Services Outcomes Research,​
Director, Health Services Outcomes Research Programme and Director
Centre for Population Health Sciences
Principal Investigator, Population Health & Living Laboratory 

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

Response: In 2018, almost 8% of people with diabetes who owned a smartphone used a diabetes app to support self-management. Currently, most apps are not regulated by the US Food and Drug Administration (FDA). We downloaded and assessed 371 diabetes self-management apps, to see if they provided evidence-based decision support and patient education.  Continue reading

Acetaminophen and Stroke Risk in Diabetic Nursing Home Patients

MedicalResearch.com Interview with:
Philippe Girard, MD,

Gérontopôle de Toulouse, CHU Toulouse
Toulouse, France

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

Response: The idea for this study came about in 2016 when a systematic review assessing acetaminophen’s adverse event (AEs) profile came out with results suggesting increased mortality and morbidity (Paracetamol: not as safe as we thought? A systematic literature review of observational studies, PMID: 25732175).

Pr Yves Rolland had collected data from his IQUARE study (Improving the Quality of Care of Long-Stay Nursing Home Residents in France, PMID: 26782872) including all prescriptions from over 6000 nursing home residents and all their medical history over an 18 month follow-up period.

We thought it would be a good idea to assess the safety profile of acetaminophen on this geriatric population.  Continue reading

Insulin Resistance Characterizes a Subset of Schizophrenia Patients

MedicalResearch.com Interview with:

Prof Sabine Bahn MD PhD MRCPsych FRSBCambridge Centre for Neuropsychiatric Research

Prof. Bahn


Prof Sabine Bahn MD PhD MRCPsych FRSB

Cambridge Centre for Neuropsychiatric Research

Jakub Tomasik, PhDDepartment of Chemical Engineering and Biotechnology

Dr. Tomasik

Jakub Tomasik, PhD
Department of Chemical Engineering and Biotechnology
University of Cambridge

 

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

Response: Schizophrenia patients are at increased risk of impaired glucose metabolism, yet the comorbidity between the two conditions cannot be fully explained by known risk factors such as obesity, smoking, stress or antipsychotic medication. Previous family and genome-wide studies have suggested that the co-occurrence between schizophrenia and impaired glucose metabolism might be due to shared genetic factors, as exemplified by increased risk of diabetes in first-degree relatives of schizophrenia patients, but the biological mechanisms underlying this association remain unknown.

We examined the association between insulin resistance, schizophrenia polygenic risk and response to treatment in 58 drug-naive schizophrenia patients and 58 matched healthy individuals while controlling for a range of demographic (age, gender, body mass index), lifestyle (smoking, alcohol and cannabis use) and clinical (psychopathology scores, treatment drug) factors.

We found that insulin resistance, a key feature contributing to the development of type 2 diabetes, significantly correlated with schizophrenia polygenic risk score in patients, with higher genetic risk of schizophrenia associated with increased insulin resistance. Furthermore, we found that patients with higher insulin resistance were more likely to switch medication during the first year of treatment, which implies lower clinical response.  Continue reading

Gene Transfer Improved Cardiac Function in Diabetic Mouse Model

MedicalResearch.com Interview with:

H. Kirk Hammond, MDProfessor of Medicine at University of California, San DiegoBasic research scientist and cardiologistSan Diego Veterans' Affairs Healthcare System

Dr. Hammond

H. Kirk Hammond, MD
Professor of Medicine at University of California
San Diego
Basic research scientist and cardiologist
San Diego Veterans’ Affairs Healthcare System

Dr. Hammond is winner of the 2017 William S. Middleton Award – the highest research honor in the U.S. Department of Veterans Affairs 

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

Response: Worldwide, 9% of adults have diabetes, predominantly due to insulin resistance, known as Type 2 diabetes. It is associated with obesity and diets high in fat and carbohydrates. In this gene transfer study we showed that a single injection of a vector encoding a natural hormone (urocortin 2, Ucn2) increased glucose disposal and improved heart function in a model of diet-induced Type 2 diabetes in mice. 

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Metformin in Pregnancy Associated With Increased Obesity in Children

MedicalResearch.com Interview with:

Liv Guro Engen Hanem, PhD CandidateDepartment of Clinical and Molecular MedicineNorwegian University of Science and Technology

Liv Guro Engen Hanem

Liv Guro Engen Hanem, PhD Candidate
Department of Clinical and Molecular Medicine
Norwegian University of Science and Technology

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

Response: The antidiabetic drug metformin is increasingly used in pregnancy: to treat gestational diabetes and type 2 diabetes, and to prevent pregnancy complications related to polycystic ovary syndrome (PCOS) and obesity. Metformin passes the placenta, and the fetus is thus exposed to the drug. Although no teratogenicity has been reported, metformin might have long-term effects on offspring health.

This study is a follow-up of cardiometabolic risk factors of 141 5- to 10-year-old children born in the PregMet study. This study was a double-blind, randomized controlled trial (RCT) designed to test the hypothesis that metformin given throughout pregnancy reduces the prevalence of pregnancy complications that are associated with the common endocrine disorder PCOS. Pregnant women with PCOS were randomized to receive metformin or placebo throughout pregnancy.  Continue reading

Smartphone App Will Be Able to Predict Diabetes

MedicalResearch.com Interview with:

Robert Avram MD MScDivision of CardiologyUniversity of California, San Francisco

Dr. Robert Avram

Robert Avram MD MSc
Division of Cardiology
University of California, San Francisco

MedicalResearch.com: What is the background for this study? Would you briefly describe what is meant by Photoplethysmography?

While analyzing the heart rate data as collected using smartphones apps in the Health-eHeart study, we noticed that diabetic patients had, on average, a higher ‘free-living’ heart rate than non-diabetic patients when adjusted from multiple factors. This pushed us to analyze the signal to see if there were other features that would help differentiate diabetes patients from non-diabetes patients. By identifying these features, we saw a huge opportunity to develop a screening tool for diabetes using deep learning and a smartphone camera and flash, in order to classify patients as having prevalent diabetes/no-diabetes.

Photoplethysmography is the technique of measuring the difference in light absorption by the skin in order to detect blood volume changes in the microvasculature. Most modern mobile devices, including smartphones and many fitness trackers (Apple Wathc, FitBit), have the ability to acquire PPG waveforms, providing a unique opportunity to detect diabetes-related vascular changes at population-scale.  Continue reading

BELVIQ®: FDA accepts sNDA To Include Long Term Safety/Efficacy Data

WeightControl.com Interview with:

Dr. Lynn Kramer, MD FAANVP and Chief Clinical Officer & Chief Medical OfficeEisai Co., Ltd

Dr. Kramer

Dr. Lynn Kramer, MD FAAN
VP and Chief Clinical Officer & Chief Medical Office
Eisai Co., Ltd

WeightControl.com: What is the background for this announcement?

Response: On February 25th, Eisai announced that the U.S. Food and Drug Administration (FDA) accepted its supplemental New Drug Application to potentially update the label for BELVIQ® (lorcaserin HCI) CIV 10 mg twice-daily/BELVIQ XR (lorcaserin HCI) CIV once daily to include long-term efficacy and safety data from CAMELLIA-TIMI 61, a clinical trial of BELVIQ in 12,000 overweight and obese patients with cardiovascular (CV) disease and/or multiple CV risk factors such as type 2 diabetes mellitus (T2DM).

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Diabetes-Risk Associated With Statin Use

MedicalResearch.com Interview with:
Fariba Ahmadizar, PharmD, MSc, PhD
Department of Epidemiology
Erasmus University Medical Centre
Rotterdam, the Netherlands

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

Response: Several observational studies and trials have already reported an increased risk of incident type 2 diabetes in subjects treated with statins; however, most of them lack details, meaning that there were limited studies on the association of statin use with glycemic traits. Studies on this association underestimated type 2 diabetes incident cases due to including either questionnaire-based data, short follow-up time or lack of a direct comparison between different statin types, dosages and duration of use with respect to diabetes-related outcomes.

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Is Behavioral Change Among Overweight Diabetics Feasible and Sustainable?

MedicalResearch.com Interview with:
Giuseppe Pugliese, MD, PhD
for the Italian Diabetes and Exercise Study 2 (IDES_2) Investigators
Department of Clinical and Molecular Medicine
‘‘La Sapienza’’ University
Diabetes Unit, Sant’Andrea University Hospital
Rome, Italy

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

Response: There is a growing epidemic of obesity and type 2 diabetes worldwide,
which are causally related to the increasing prevalence of “physical
inactivity”, i.e., an insufficient amount of moderate-to-vigorous
physical activity according to current guidelines, and
“sedentariness”, i.e., too many hours, especially if uninterrupted,
spent in a sitting or reclined position.  These two unhealthy
behaviors exert their detrimental effects independently of each other
and are very common among people suffering from type 2 diabetes, who
would therefore benefit from increasing physical activity and reducing
sedentary time, as recommended by current guidelines.

However, such a behavior change is generally difficult for a number of
internal and external barriers and requires behavioral interventions
targeting both physical activity and sedentary habits.  Unfortunately,
there is no definitive evidence that this is indeed feasible and,
particularly, that, if adopted, change in behavior can be maintained
in the long term.  Continue reading

Pioglitazone (Actos) Reduced Risk of Secondary Stroke and New Onset of Diabetes

MedicalResearch.com Interview with:

David Spence M.D., FRCPC, FAHA Professor of Neurology and Clinical Pharmacology Director, Stroke Prevention & Atherosclerosis Research Centre, Robarts Research Institute, Western University London, ON Canada

Dr. Spence

David Spence M.D., FRCPC, FAHA
Professor of Neurology and Clinical Pharmacology
Director, Stroke Prevention & Atherosclerosis Research Centre,
Robarts Research Institute, Western University
London, ON Canada

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

Response: The motivation for the study was the chair of the committee that advises the Ontario Drug Benefit which medications to pay for said the IRIS results were not relevant to clinical practice. This because the Insulin Resistance Intervention after Stroke (IRIS) trial reported effects of pioglitazone in patients with stroke or TIA and insulin resistance assessed by the Homeostasis Model Assessment of Insulin Resistance (HOMA-IR) score for insulin resistance.1 ( However, few clinicians measure a HOMA-iR score, so the clinical impact of that trial was limited.

In this study we analyzed the effect of pioglitazone in stroke/TIA patients with prediabetes, which is commonly assessed by clinicians. Prediabetes was defined by the American Diabetes Association: a glycosylated hemoglobin (A1C) of  5.7% to <6.5% (we did not do glucose tolerance tests).  We analyzed primarily the results for patients with 80% adherence, but also did  an intention-to-treat (ITT) analysis.  The reason for focusing on patients with good adherence was that pioglitazone cannot be taken by about 10-20% of patients, because of fluid retention and weight gain (mainly due  to fluid retention).  (The reasoning was that third party payers would not need to pay for the medication in patients who do not take it.)

In stroke/TIA patients with good adherence, the benefits of pioglitazone were greater than in the original IRIS trial. We found a 40% reduction of stroke/MI, a 33% reduction of stroke, and an 80% reduction of new-onset diabetes, over 5 years.  Pioglitazone also improved blood pressure, triglycerides and HDL-cholesterol. As expected, pioglitazone was somewhat less beneficial in the ITT analysis.

Fluid retention can usually be managed by reducing the dose of pioglitazone; even small doses still have a beneficial effect . Also, amiloride has been shown to reduce fluid retention with pioglitazone.

  1. Kernan WN, Viscoli CM, Furie KL, Young LH, Inzucchi SE, Gorman M, Guarino PD, Lovejoy AM, Peduzzi PN, Conwit R, Brass LM, Schwartz GG, Adams HP, Jr., Berger L, Carolei A, Clark W, Coull B, Ford GA, Kleindorfer D, O’Leary JR, Parsons MW, Ringleb P, Sen S, Spence JD, Tanne D, Wang D, Winder TR and Investigators IT. Pioglitazone after Ischemic Stroke or Transient Ischemic Attack. N Engl J Med. 2016;374:1321-31. 

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Stroke: Intensive Blood Sugar Control Did Not Improve Outcomes

MedicalResearch.com Interview with:

Prof-Karen-C-Johnston

Prof. Johnston

Karen C. Johnston MD
Professor and Chair, Neurology
School of Medicine
University of Virginia

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

Response: We know that acute ischemic stroke patient with hyperglycemia at presentation have worse outcomes. We also know if we lower the glucose too low that this is bad for ischemic brain also. T

he SHINE trial addressed a world wide debate about whether intensive treatment of hyperglycemia is beneficial. We assessed the efficacy and safety of an intensive glucose control protocol with a target glucose of 80-130 mg/dL compared to a more standard protocol with a target of less than 180 mg/dL.

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Gastric Bypass Surgery Linked to Diabetes Remission

MedicalResearch.com Interview with:
Lene Ring Madsen, MD, Ph.d.
Medicinsk Afdeling  Herning
Hospitalsenheden Vest

Lene Ring Madsen, MD, Ph.d. Medicinsk Afdeling  Herning Hospitalsenheden Vest
MedicalResearch.com: What is the background for this study? What are the main findings?

Response: We know from previous studies that there is a significant chance of diabetes remission following Roux-en-Y gastric bypass, but most studies evaluate smaller cohorts of selected patients (e.g. from a single center or only patients covered by a specific type of insurance). By using Danish registries, which hold information on all Danish Citizens independent of social- or economic status and have complete follow-up, we wanted to evaluate the Roux-en-Y gastric bypass surgery (RYGB) in a real-world setting.

The main findings are that more than 70 % of patients with obesity (BMI>35 kg/m2) and type 2 diabetes treated by RYGB had their diabetes go into remission or every 6-month period in the first 5 years after the procedure. Out of those who were in remission within the first year of follow-up 27% had undergone relapse at 5 years.

The most important predictor of a patient not going into remission was if they required insulin to control their disease. Other factors included older age and higher starting HbA1c level. During the more than five years of follow-up, the risk of microvascular complications was 47% lower in the RYGB group than in the control population, with largest decreases in the risk of diabetic retinopathy and diabetic kidney disease. There was a smaller impact on the risk of macrovascular events, which were 24% lower among patients who had received bariatric surgery; however, this difference was not large enough to achieve statistical significance. The 90-day mortality was very low (<0.5%).

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Study Find No Difference in Standardized Test Scores in Children With/Without Diabetes

MedicalResearch.com Interview with:

Niels Skipper PhD Associate Professor, Department of Economics and Business Economics Aarhus University

Dr. Skipper

Niels Skipper PhD
Associate Professor, Department of Economics and Business Economics
Aarhus University

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

Response: It is unclear if there is an association between type 1 diabetes and school performance in children. Some studies have found type 1 diabetes to be associated with worse performance, while others have found no differences. However, most of the existing literature are based on smaller, non-random samples of children with diabetes. In this study we used data on all public school children in the country of Denmark, involving more than 600,000 schoolchildren where approximately 2,000 had a confirmed diagnosis of type 1 diabetes. The children were tested in math and reading using a nationally standardized testing procedure, and we found no difference in the obtain test scores between children with diabetes compared to children without diabetes.  Continue reading

Primary Care Settings Offer Opportunity for Wider Screening for Diabetic Retinopathy

MedicalResearch.com Interview with:

Diane M. Gibson, Ph.D. Executive Director – New York Federal Statistical Research Data Center, Baruch RDC Associate Professor – Marxe School of Public and International Affairs, Baruch College - CUNY

Dr. Gibson

Diane M. Gibson, Ph.D.
Executive Director – New York Federal Statistical Research Data Center, Baruch RDC
Associate Professor – Marxe School of Public and International Affairs, Baruch College – CUNY

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

Response: Prior studies have found that screening for diabetic retinopathy in primary care settings using telemedicine increased screening rates among individuals with diabetes and among subgroups of individuals with diabetes who are at high risk of missing recommended eye exams.  In a previous paper I looked at how often U.S. adults with diabetes visited primary care and eye care providers for recommended diabetes preventive care services using a sample from the 2007-2013 Medical Expenditure Panel Survey.  I found that while visits to eye care providers were often skipped, most adults with diabetes did visit primary care physicians.  I argued that these findings suggest that screening for diabetic retinopathy in primary care settings using telemedicine has the potential to fulfill unmet needs and reach most U.S. adults with diabetes.

My brief report in JAMA Ophthalmology examines patterns of eye examination receipt and visits to primary care physicians among U.S. adults with diabetes using a sample from the 2016 National Health Interview Survey.  The report pays particular attention to individuals who are at high-risk of missing recommended eye exams.

The study found that 87.7% of the sample of adults with diabetes visited a primary care physician in the past year and that, except for the uninsured subgroup, more than 78% of each high-risk subgroup visited a primary care provider in the past year.  Continue reading

Going to Bed Right After Dinner May Raise Diabetes Risk

MedicalResearch.com Interview with:
Chiyori Haga, R.N. P.H.N Ph.D
Department of Community Nursing
Graduate School of Health Science
Okayama University in Japan

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

Response: In Japan, we have a health checkup system for middle and elderly people to prevent their non-communicable diseases (NCDs) including the Metabolic Syndrome (MetS) and give them some health guidance based a guideline. The guideline has suggested that short duration between bed time and dinner time will be a risk factor of metabolic syndrome or diabetes mellitus for some duration.

However, there may be no association between them, it is the main findings.  Continue reading