Clinical trial NCT02045290: Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
Official title: Metformin Therapy for Overweight Adolescents With Type 1 Diabetes (T1D)--Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Type 1 Diabetes
Lead sponsor: Jaeb Center for Health Research
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
First posted: 2014-01-24
Enrollment: 37
Sex: ALL
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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%).


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

Primary outcomes:
measure: Change in insulin resistance (IR) from baseline to 13 weeks
timeFrame: 0-13 weeks
Secondary outcomes:
measure: Change in Hepatic IR from baseline to 13 weeks
timeFrame: 0-13 weeks
measure: Change in Adipose IR from baseline to 13 weeks
timeFrame: 0-13 weeks
Other outcomes:
Locations:
city: Tampa
country: United States
facility: Jaeb Center for Health Research
state: Florida
Study officials:
affiliation: Jaeb Center for Health Research
name: Kellee M Miller, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Childrens Hospital of University of Pittsburgh Medical Center
name: Ingrid Libman, MD, PhD
role: STUDY_CHAIR
affiliation: University of Colorado Denver/Childrens Hospital Colorado
name: Kristen Nadeau, MD
role: STUDY_CHAIR
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