Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
Overview[ - collapse ][ - ]
Purpose | 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 6-month randomized trial comparing metformin versus placebo in 12 to <20 year olds with BMI >85th percentile ( total daily insulin dose >0.8 units/kg, and HbA1c 7.5%-9.9%). |
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Condition | Type 1 Diabetes |
Intervention | Drug: Metformin Drug: Placebo |
Phase | Phase 3 |
Sponsor | T1D Exchange Clinic Network Coordinating Center |
Responsible Party | T1D Exchange Clinic Network Coordinating Center |
ClinicalTrials.gov Identifier | NCT02045290 |
First Received | January 15, 2014 |
Last Updated | January 22, 2014 |
Last verified | January 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | January 15, 2014 |
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Last Updated Date | January 22, 2014 |
Start Date | January 2014 |
Estimated Primary Completion Date | April 2015 |
Current Primary Outcome Measures | Change in insulin resistance (IR) from baseline to 13 weeks [Time Frame: 0-13 weeks] [Designated as safety issue: No]Hyperinsulinemic euglycemic clamp to assess metformin's impact on muscle IR via glucose infusion rate (GIR). |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | Insulin Clamp Ancillary Study for Assessment of Insulin Resistance |
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Official Title | Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance |
Brief Summary | 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 6-month randomized trial comparing metformin versus placebo in 12 to <20 year olds with BMI >85th percentile ( total daily insulin dose >0.8 units/kg, and HbA1c 7.5%-9.9%). |
Detailed Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Type 1 Diabetes |
Intervention | Drug: Metformin 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. Drug: Placebo |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 44 |
Estimated Completion Date | April 2015 |
Estimated Primary Completion Date | January 2015 |
Eligibility Criteria | 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 |
Gender | Both |
Ages | 12 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Kellee M Miller, MPH 813-975-8690 t1dstats@jaeb.org |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT02045290 |
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Other Study ID Numbers | T1DX Insulin Clamp Ancillary |
Has Data Monitoring Committee | Yes |
Information Provided By | T1D Exchange Clinic Network Coordinating Center |
Study Sponsor | T1D Exchange Clinic Network Coordinating Center |
Collaborators | Juvenile Diabetes Research Foundation |
Investigators | Principal Investigator: Kellee M Miller, MPH Jaeb Center for Health ResearchStudy Chair: Ingrid Libman, MD, PhD Childrens Hospital of University of Pittsburgh Medical CenterStudy Chair: Kristen Nadeau, MD University of Colorado Denver/Childrens Hospital Colorado |
Verification Date | January 2014 |
Locations[ + expand ][ + ]
Jaeb Center for Health Research | Tampa, Florida, United States, 33647 Contact: Kellee M Miller, MPH | 813-975-8690 | t1dstats@jaeb.orgPrincipal Investigator: Kellee M Miller, MPH Recruiting |
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