Rosiglitazone and Insulin in T1DM Adolescents

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.

Official Title

The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

Conditions

Type 1 Diabetes

Study Type

Interventional

Study Design

Treatment, Randomized, Double-Blind, Placebo Control, Crossover Assignment, Safety/Efficacy Study

Further Details

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

Study Start

August 2003; Study completion: September 2005

Eligibility & Criteria

• Ages Eligible for Study: 10 Years – 18 Years
• Genders Eligible for Study: Both

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

Total Enrolment

32

Contact Details

Sydney Children’s Hospital, Sydney, New South Wales, 2038, Australia

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