Rosiglitazone and Insulin in T1DM Adolescents

September 3, 2006 updated by: The University of New South Wales

The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

32

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2038
        • Sydney Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • T1DM duration > 1year
  • age 10-18years
  • HbA1c > 8%
  • puberty > Tanner stage 2 breast or testis >4ml

Exclusion Criteria:

  • known non-compliance
  • hypo unaware

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
HbA1c

Secondary Outcome Measures

Outcome Measure
weight
adiponectin
insulin dose
frequency of severe hypoglycaemia
insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
BMI-SDS
skin fold thickness
cholesterol

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Collaborators

National Health and Medical Research Council, Australia
Novo Nordisk A/S
Sydney Children's Hospitals Network

Investigators

  • Principal Investigator: Monique Stone, MBBS FRACP, Royal North Shore Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2003

Study Completion

September 1, 2005

Study Registration Dates

First Submitted

September 3, 2006

First Submitted That Met QC Criteria

September 3, 2006

First Posted (Estimate)

September 6, 2006

Study Record Updates

Last Update Posted (Estimate)

September 6, 2006

Last Update Submitted That Met QC Criteria

September 3, 2006

Last Verified

September 1, 2006

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 02/315
  • JHH ethics: 04/02/11/3.04
  • CHW ethics: 2003/037

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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