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| Name | Class |
|---|---|
| Juvenile Diabetes Research Foundation | OTHER |
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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%).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Placebo | Placebo Comparator | A central pharmacy will compound a placebo to match the metformin tablets. The placebo product will contain the following components:
|
|
| Metformin | Experimental | Metformin 2000 mg per day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Metformin | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 0-13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 0-13 weeks |
| Change in Adipose IR from baseline to 13 weeks |
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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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| Name | Affiliation | Role |
|---|---|---|
| Kellee M Miller, MPH | Jaeb Center for Health Research | Principal Investigator |
| Ingrid Libman, MD, PhD | Childrens Hospital of University of Pittsburgh Medical Center | Study Chair |
| Kristen Nadeau, MD | University of Colorado Denver/Childrens Hospital Colorado | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jaeb Center for Health Research | Tampa | Florida | 33647 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 14514603 | Background | Snell-Bergeon JK, Hokanson JE, Jensen L, MacKenzie T, Kinney G, Dabelea D, Eckel RH, Ehrlich J, Garg S, Rewers M. Progression of coronary artery calcification in type 1 diabetes: the importance of glycemic control. Diabetes Care. 2003 Oct;26(10):2923-8. doi: 10.2337/diacare.26.10.2923. | |
| 15677783 | Background |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D008687 | Metformin |
| ID | Term |
|---|---|
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 | Amidines |
| D009930 | Organic Chemicals |
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|
| Placebo | Drug |
|
Graded hyperinsulinemic euglycemic clamp with glucose and glycerol isotopes to assess metformin's impact on:
• Adipose IR
| 0-13 weeks |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |