The objective of the proposed research is to evaluate the efficacy and safety of the use of metformin in addition to standard insulin therapy in overweight and obese children and adolescents, age 12-\<20 years, with type 1 diabetes for at least 1 year. Secondary objectives are to assess the effect of metformin on C-peptide levels, a measure of how much insulin is still being produced by the beta cells of the pancreas, and on vascular dysfunction. In addition, an ancillary study is planned to assess if metformin will improve tissue-specific insulin resistance in type 1 diabetes using a hyperinsulinemic euglycemic clamp.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
164
The strength of each tablet will be 500 mg. Participants will build up to a daily dose over four weeks by taking one tablet per day for 7 days, one tablet twice daily for 7 days, one tablet in morning and 2 tablets at night for 7 days, and then 2 tablets in the morning and 2 tablets at night, daily throughout the remainder of the study treatment period.
Jaeb Center for Health Research
Tampa, Florida, United States
Change in Hemoglobin A1c From Baseline to 26 Weeks, Adjusted for Baseline Hemoglobin A1c.
Hemoglobin A1c is a measure of glycemic control over approximately the past 3 months
Time frame: 0-26 weeks
Change in Total Daily Dose of Insulin (TDI) Per kg
Time frame: 0-26 weeks
Change in Body Mass Index (BMI)
Time frame: 0-26 weeks
Change in Waist Circumference
Time frame: 0-26 weeks
Change in Body Composition
Change in percent body fat
Time frame: 0-26 weeks
Change in Serum Lipids
Time frame: 0-26 weeks
Change in Blood Pressure
Time frame: 0-26 weeks
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