NCT00372086

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Aug 2003

Typical duration for phase_4

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
2.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

September 3, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 6, 2006

Completed
Last Updated

September 6, 2006

Status Verified

September 1, 2006

First QC Date

September 3, 2006

Last Update Submit

September 3, 2006

Conditions

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

Outcome Measures

Primary Outcomes (1)

  • HbA1c

Secondary Outcomes (8)

  • insulin dose

  • frequency of severe hypoglycaemia

  • insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp

  • weight

  • BMI-SDS

  • +3 more secondary outcomes

Interventions

RosiglitazoneDRUG

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • known non-compliance
  • hypo unaware

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sydney Children's Hospital

Sydney, New South Wales, 2038, Australia

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Rosiglitazone

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

ThiazolidinedionesThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Monique Stone, MBBS FRACP

    Royal North Shore Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 3, 2006

First Posted

September 6, 2006

Study Start

August 1, 2003

Study Completion

September 1, 2005

Last Updated

September 6, 2006

Record last verified: 2006-09

Locations

AU(1)