Insulin Clamp Ancillary Study for Assessment of Insulin Resistance
NCT ID: NCT02045290
Last Updated: 2017-03-14
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
37 participants
Study Classification
INTERVENTIONAL
Study Start Date
2014-01-31
Study Completion Date
2016-02-15
Brief Summary
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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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Detailed Description
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Conditions
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Type 1 Diabetes
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
QUADRUPLE
Participants
Caregivers
Investigators
Outcome Assessors
Study Groups
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Oral Placebo
A central pharmacy will compound a placebo to match the metformin tablets.
The placebo product will contain the following components:
* Micosolle™, silica based excipient
* Silicified Micro Crystalline Cellulose, National Formulary
* Safflower Oil, United States Pharmacopeia
* K-30 Povidone Powder
* Magnesium Stearate, National Formulary (Vegetable source)
* Fumed Silica, National Formulary
Group Type
PLACEBO_COMPARATOR
Placebo
Intervention Type
DRUG
Metformin
Metformin 2000 mg per day
Group Type
EXPERIMENTAL
Metformin
Intervention Type
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.
Interventions
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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.
Intervention Type
DRUG
Placebo
Intervention Type
DRUG
Eligibility Criteria
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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
Minimum Eligible Age
12 Years
Maximum Eligible Age
19 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Juvenile Diabetes Research Foundation
OTHER
Sponsor Role
collaborator
Jaeb Center for Health Research
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Kellee M Miller, MPH
Role: PRINCIPAL_INVESTIGATOR
Jaeb Center for Health Research
Ingrid Libman, MD, PhD
Role: STUDY_CHAIR
Childrens Hospital of University of Pittsburgh Medical Center
Kristen Nadeau, MD
Role: STUDY_CHAIR
University of Colorado Denver/Childrens Hospital Colorado
Locations
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Jaeb Center for Health Research
Tampa, Florida, United States
Site Status
Countries
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United States
References
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Reference Type
DERIVED
Other Identifiers
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T1DX Insulin Clamp Ancillary
Identifier Type: -
Identifier Source: org_study_id
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