Insulin Clamp Ancillary study for Assessment of Insulin Resistance will be conducted as a sub-study to the main protocol, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828). The purpose of this ancillary study is to assess if metformin will improve tissue-specific insulin resistance (IR) in type 1 diabetes using a hyperinsulinemic euglycemic clamp; a 3-month randomized trial comparing metformin versus placebo in 12 to \<20 year olds with BMI \>85th percentile ( total daily insulin dose \>0.7 units/kg, and HbA1c 7.0%-9.9%).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
37
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 the 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 insulin resistance (IR) from baseline to 13 weeks
Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR).
Time frame: 0-13 weeks
Change in Hepatic IR from baseline to 13 weeks
Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Hepatic IR
Time frame: 0-13 weeks
Change in Adipose IR from baseline to 13 weeks
Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on: • Adipose IR
Time frame: 0-13 weeks
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