Rosiglitazone and Insulin in T1DM Adolescents

Phase 4

Completed

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

• Registration Number: NCT00372086
• Lead Sponsor: The University of New South Wales

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-08
• Study Completion: 2005-09
• Status Verified: 2006-09
• Study First Submitted: 2006-09-03
• Study First Submitted QC: 2006-09-03
• Last Update Submitted: 2006-09-03
• Study First Posted: 2006-09-06
• Last Update Posted: 2006-09-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

Inclusion Criteria

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

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Exclusion Criteria

• known non-compliance
• hypo unaware

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
HbA1c

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sydney Children's Hospital; 🇦🇺 Sydney, New South Wales, Australia