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
About this trial
This is an interventional treatment trial for Type 1 Diabetes
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
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
NCT ID
NCT00372086
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
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
Learn more about this trial
Rosiglitazone and Insulin in T1DM Adolescents
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