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. |
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Condition | Insulin Resistance Diabetes Mellitus |
Intervention | Drug: Metformin Procedure: skin biopsy Behavioral: diet and exercise Drug: pioglitazone Drug: rosiglitazone |
Phase | Phase 2 |
Sponsor | National Center for Research Resources (NCRR) |
Responsible Party | National Center for Research Resources (NCRR) |
ClinicalTrials.gov Identifier | NCT00015626 |
First Received | April 24, 2001 |
Last Updated | June 23, 2005 |
Last verified | December 2003 |
Tracking Information[ + expand ][ + ]
First Received Date | April 24, 2001 |
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Last Updated Date | June 23, 2005 |
Start Date | Not Provided |
Estimated Primary Completion Date | Not Provided |
Current Primary Outcome Measures | Not Provided |
Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | A Clinical Trial to Prevent the Complications of Insulin Resistance (Including Type-2 Diabetes) |
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Official Title | A 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 Description | Not Provided |
Study Type | Interventional |
Study Phase | Phase 2 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment |
Condition |
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Intervention | Drug: Metformin Procedure: skin biopsy Behavioral: diet and exercise Drug: pioglitazone Drug: rosiglitazone |
Study Arm (s) | Not Provided |
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
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Estimated Enrollment | 300 |
Estimated Completion Date | Not Provided |
Estimated Primary Completion Date | Not 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 |
Gender | Both |
Ages | 5 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00015626 |
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Other Study ID Numbers | NCRR-M01RR06020-0057 |
Has Data Monitoring Committee | Not Provided |
Information Provided By | National Center for Research Resources (NCRR) |
Study Sponsor | National Center for Research Resources (NCRR) |
Collaborators | Not Provided |
Investigators | Not Provided |
Verification Date | December 2003 |
Locations[ + expand ][ + ]
Cornell University | New York, New York, United States, 10021 |
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