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Rosiglitazone and Insulin in T1DM Adolescents

NCT00372086 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2006-09-06

No results posted yet for this study

Summary

Type 1 Diabetes is the most common life-long disorder with onset in childhood. Patients need insulin injections, blood sugar monitoring several times each day, and adhere to a strict diet. Adequate control of blood glucose is essential to prevent long term kidney and eye complications that result in kidney failure and blindness. Adolescence is a time when diabetes is difficult to control, due in part to high growth hormone levels causing insulin resistance ( a state where the body does not respond as strongly to insulin). This study will test whether treatment with rosiglitazone (an oral medication used frequently in type 2 diabetes) will reduce the insulin resistance of adolescence and improve the control of type 1 diabetes during puberty.

Conditions

Interventions

DRUG

Rosiglitazone

Sponsors & Collaborators

  • Sydney Children's Hospitals Network

    collaborator OTHER

  • National Health and Medical Research Council, Australia

    collaborator OTHER

  • Novo Nordisk A/S

    collaborator INDUSTRY

  • The University of New South Wales

    lead OTHER

Principal Investigators

  • Monique Stone, MBBS FRACP · Royal North Shore Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-08-31
Completion
2005-09-30

Countries

  • Australia

Study Locations

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Diseases
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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00372086 on ClinicalTrials.gov