Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
| Status: | Completed |
|---|---|
| Conditions: | Endocrine, Diabetes, Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 12 - 19 |
| Updated: | 4/2/2016 |
| Start Date: | January 2014 |
| End Date: | April 2015 |
| Contact: | Kellee M Miller, MPH |
| Email: | t1dstats@jaeb.org |
| Phone: | 813-975-8690 |
Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
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%).
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%).
Inclusion Criteria:
1. Meets eligibility criteria of the main study, Metformin Therapy for Overweight
Adolescents With Type 1 Diabetes (NCT01881828).
Exclusion Criteria:
1. 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
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