Back to resultsA Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Primary Purpose
Insulin Resistance, Diabetes Mellitus
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
skin biopsy
diet and exercise
pioglitazone
rosiglitazone
Sponsored by
About this trial
This is an interventional treatment trial for Insulin Resistance
Eligibility Criteria
Inclusion criteria: Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT. Family history of type II diabetes. Exclusion Criteria: Critically ill patients, patients will congestive heart failure, renal or liver insufficiency Inability to give consent. History of poor compliance with physician's recommendations
Sites / Locations
- Cornell University
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00015626
First Posted
April 24, 2001
Last Updated
June 23, 2005
Sponsor
National Center for Research Resources (NCRR)
1. Study Identification
Unique Protocol Identification Number
NCT00015626
Brief Title
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Official Title
A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2003
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Center for Research Resources (NCRR)
4. Oversight
5. Study Description
Brief Summary
The goal of this study is to aggressively treat insulin resistance and its clinical manifestations when they first appear in childhood, and to prevent the subsequent progression towards impaired glucose tolerance and type-2 diabetes. In the process of this clinical trial, we will learn more about the early manifestations of insulin resistance, its treatment, and its relationship to obesity and type-2 diabetes through parallel in-vivo and in-vitro studies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized
Enrollment
300 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Type
Procedure
Intervention Name(s)
skin biopsy
Intervention Type
Behavioral
Intervention Name(s)
diet and exercise
Intervention Type
Drug
Intervention Name(s)
pioglitazone
Intervention Type
Drug
Intervention Name(s)
rosiglitazone
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Obese patients (wt > 95th percentile for age, for adults increased BMI > 27) greater than 5 years of age
And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism
Siblings and parents of patients with insulin resistance. Siblings and parents will be included only in the case of documented insulin resistance in the index subject. Insulin resistance will be documented by OGTT and/or IVGTT.
Family history of type II diabetes.
Exclusion Criteria:
Critically ill patients, patients will congestive heart failure, renal or liver insufficiency
Inability to give consent.
History of poor compliance with physician's recommendations
Facility Information:
Facility Name
Cornell University
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
33210751
Citation
Ipsen EO, Madsen KS, Chi Y, Pedersen-Bjergaard U, Richter B, Metzendorf MI, Hemmingsen B. Pioglitazone for prevention or delay of type 2 diabetes mellitus and its associated complications in people at risk for the development of type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Nov 19;11(11):CD013516. doi: 10.1002/14651858.CD013516.pub2.
Results Reference
derived
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A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
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