Insulin Clamp Ancillary Study for Assessment of Insulin Resistance

Completed · Phase 3 · Has a placebo group

Conditions studied: Type 1 Diabetes

In brief

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%).

Key facts

Study ID

NCT02045290

Run by

Jaeb Center for Health Research

People needed

37

Starts

2014-01-01

Expected to finish

2016-02-15

Last updated by the study team

2017-03-14

Who can join

Age: 12 and older, up to 19. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Meets eligibility criteria of the main study, Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (NCT01881828).

You may not qualify if…

• Low hemoglobin or hematocrit as defined by each local institution's rules for insulin clamps or if no institutional requirements a Hematocrit <30% or hemoglobin <10 gm/dL

Where it is running

• Jaeb Center for Health Research — Tampa, Florida, United States

Full record on ClinicalTrials.gov

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