A study of an oral medication at the Naomi Berrie Diabetes Center will bring much needed new information to help treat the effects of a problem that clinicians caring for people with type 1 diabetes (T1D) are increasingly recognizing. Patients with T1D, particularly teenagers, are becoming overweight or obese and this can be a big problem for diabetes management.
“Patients with T1D are traditionally thought to be thin,” said Dr. Mary Pat Gallagher, head of the pediatric diabetes program at the Berrie Center and a co-investigator on this trial. “But as the whole population gets heavier, so does this population of teens with T1D.” Added Dr. Rachelle Gandica, a Berrie Center pediatric endocrinologist and a co-investigator, as many as one in five teens with T1D may be overweight—which is similar to the rate of obesity in the general population. Risk for weight gain in T1D is increased further if there are frequent low blood sugars with need for frequent treatment with sugary and calorie-laden snacks.
Being overweight can have major consequences for everyone, but for teens with T1D, the health risks can be magnified. An increased body weight causes insulin resistance, a condition in which increasing amounts of insulin are required to normalize blood sugar. The insulin resistance conferred by weight gain is a particular problem in adolescence because puberty itself is also known to cause insulin resistance. The combination of obesity together with puberty may cause very difficult-to-control blood sugars, despite very large doses of insulin, in many overweight teens with T1D.
The aim of this multi-center study is to determine the safety and efficacy of metformin when taken in conjunction with insulin on overweight teens with T1D. Researchers will also be following the effect of the drug on blood glucose levels and on c-peptide performance. Metformin is an FDA-approved medication used to treat type 2 diabetes in adults and teens. It works by improving insulin resistance. In this study, overweight patients with poorly controlled T1D between the of ages 12 and 19 are eligible to participate.
Six subjects will be enrolled from the Berrie Center in this study; a total of 150 subjects will be enrolled from 30 centers across the country. The study is randomized and placebo-controlled, meaning that half of the subjects will receive metformin and half will receive a sugar pill (placebo), along with their usual insulin regimen. The investigators and subjects will not know, until after the study is complete, whether the subject received metformin or the placebo.
The study is funded by the Leona M. and Harry B. Helmsley Charitable Trust and is being organized by the T1D Exchange Clinic Network Coordinating Center and the Jaeb Center for Health Research in Tampa, Florida. Dr. Robin Goland is the Berrie Center Principal Investigator, Ellen Greenberg, MS, is the Lead Coordinator and Amy Wolk, RN is the Research Nurse. Additional funding for this study comes from the Juvenile Diabetes Research Foundation (JDRF).
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