NCT00015626

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 24, 2001

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 26, 2001

Completed
Last Updated

June 24, 2005

Status Verified

December 1, 2003

First QC Date

April 24, 2001

Last Update Submit

June 23, 2005

Conditions

Insulin ResistanceDiabetes Mellitus

Interventions

MetforminDRUG
skin biopsyPROCEDURE
diet and exerciseBEHAVIORAL
pioglitazoneDRUG
rosiglitazoneDRUG

Eligibility Criteria

Age5 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Critically ill patients, patients will congestive heart failure, renal or liver insufficiency
  • Inability to give consent.
  • History of poor compliance with physician's recommendations

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cornell University

New York, New York, 10021, United States

Location

Related Publications (1)

  • 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.

    PMID: 33210751DERIVED

MeSH Terms

Conditions

Insulin ResistanceDiabetes Mellitus

Interventions

MetforminDietExercisePioglitazoneRosiglitazone

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic ChemicalsNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological PhenomenaMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaThiazolidinedionesThiazolesSulfur CompoundsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

April 24, 2001

First Posted

April 26, 2001

Last Updated

June 24, 2005

Record last verified: 2003-12

Locations

US(1)