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Rosiglitazone and Insulin in T1DM Adolescents

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Rosiglitazone
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All Sexes

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

Sites / Locations

  • Sydney Children's Hospital

Outcomes

Primary Outcome Measures

HbA1c

Secondary Outcome Measures

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

Full Information

First Posted
September 3, 2006
Last Updated
September 3, 2006
Sponsor
The University of New South Wales
Collaborators
Sydney Children's Hospitals Network, National Health and Medical Research Council, Australia, Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00372086
Brief Title
Rosiglitazone and Insulin in T1DM Adolescents
Official Title
The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2006
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
The University of New South Wales
Collaborators
Sydney Children's Hospitals Network, National Health and Medical Research Council, Australia, Novo Nordisk A/S

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Puberty: >Tanner 2 Breast Development or Testis >4ml

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Double
Allocation
Randomized
Enrollment
32 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Rosiglitazone
Primary Outcome Measure Information:
Title
HbA1c
Secondary Outcome Measure Information:
Title
insulin dose
Title
frequency of severe hypoglycaemia
Title
insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp
Title
weight
Title
BMI-SDS
Title
skin fold thickness
Title
cholesterol
Title
adiponectin

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Monique Stone, MBBS FRACP
Organizational Affiliation
Royal North Shore Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sydney Children's Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2038
Country
Australia

12. IPD Sharing Statement

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Rosiglitazone and Insulin in T1DM Adolescents

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