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A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)

NCT ID: NCT00015626

Last Updated: 2005-06-24

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

PHASE2

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Brief Summary

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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.

Detailed Description

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Conditions

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Insulin Resistance Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Metformin

Intervention Type DRUG

skin biopsy

Intervention Type PROCEDURE

diet and exercise

Intervention Type BEHAVIORAL

pioglitazone

Intervention Type DRUG

rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Obese patients (wt \> 95th percentile for age, for adults increased BMI \> 27) greater than 5 years of age
2. And/or presence of complications of insulin resistance such as acanthosis nigricans, dyslipidemia, elevated blood pressure, hyperandrogenism
3. 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.
4. Family history of type II diabetes.

Exclusion Criteria

1. Critically ill patients, patients will congestive heart failure, renal or liver insufficiency
2. Inability to give consent.
3. History of poor compliance with physician's recommendations
Minimum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Center for Research Resources (NCRR)

NIH

Sponsor Role lead

Locations

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Cornell University

New York, New York, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33210751 (View on PubMed)

Other Identifiers

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NCRR-M01RR06020-0057

Identifier Type: -

Identifier Source: org_study_id