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Rosiglitazone and Insulin in T1DM Adolescents

NCT ID: NCT00372086

Last Updated: 2006-09-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-08-31

Study Completion Date

2005-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Type 1 Diabetes Puberty: >Tanner 2 Breast Development or Testis >4ml

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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Rosiglitazone

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sydney Children's Hospitals Network

OTHER

Sponsor Role collaborator

National Health and Medical Research Council, Australia

OTHER

Sponsor Role collaborator

Novo Nordisk A/S

INDUSTRY

Sponsor Role collaborator

The University of New South Wales

OTHER

Sponsor Role lead

Principal Investigators

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Monique Stone, MBBS FRACP

Role: PRINCIPAL_INVESTIGATOR

Royal North Shore Hospital

Locations

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Sydney Children's Hospital

Sydney, New South Wales, Australia

Site Status

Countries

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Australia

Other Identifiers

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JHH ethics: 04/02/11/3.04

Identifier Type: -

Identifier Source: secondary_id

CHW ethics: 2003/037

Identifier Type: -

Identifier Source: secondary_id

02/315

Identifier Type: -

Identifier Source: org_study_id