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

Overview[ - collapse ][ - ]

Purpose 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.
ConditionInsulin Resistance
Diabetes Mellitus
InterventionDrug: Metformin
Procedure: skin biopsy
Behavioral: diet and exercise
Drug: pioglitazone
Drug: rosiglitazone
PhasePhase 2
SponsorNational Center for Research Resources (NCRR)
Responsible PartyNational Center for Research Resources (NCRR)
ClinicalTrials.gov IdentifierNCT00015626
First ReceivedApril 24, 2001
Last UpdatedJune 23, 2005
Last verifiedDecember 2003

Tracking Information[ + expand ][ + ]

First Received DateApril 24, 2001
Last Updated DateJune 23, 2005
Start DateNot Provided
Estimated Primary Completion DateNot Provided
Current Primary Outcome MeasuresNot Provided
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleA Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
Official TitleA Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes)
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.
Detailed DescriptionNot Provided
Study TypeInterventional
Study PhasePhase 2
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment
Condition
  • Insulin Resistance
  • Diabetes Mellitus
InterventionDrug: Metformin
Procedure: skin biopsy
Behavioral: diet and exercise
Drug: pioglitazone
Drug: rosiglitazone
Study Arm (s)Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment StatusCompleted
Estimated Enrollment300
Estimated Completion DateNot Provided
Estimated Primary Completion DateNot Provided
Eligibility Criteria
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
GenderBoth
Ages5 Years
Accepts Healthy VolunteersNo
ContactsNot Provided
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT00015626
Other Study ID NumbersNCRR-M01RR06020-0057
Has Data Monitoring CommitteeNot Provided
Information Provided ByNational Center for Research Resources (NCRR)
Study SponsorNational Center for Research Resources (NCRR)
CollaboratorsNot Provided
Investigators Not Provided
Verification DateDecember 2003

Locations[ + expand ][ + ]

Cornell University
New York, New York, United States, 10021