Rosiglitazone and Insulin in T1DM Adolescents

Condition(s) targeted: Type 1 Diabetes; Puberty: >Tanner 2 Breast Development or Testis >4ml

Intervention: Rosiglitazone (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: The University of New South Wales

Official(s) and/or principal investigator(s):
Monique Stone, MBBS FRACP, Principal Investigator, Affiliation: Royal North Shore Hospital

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

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

Primary outcome: HbA1c

Secondary outcome:

insulin dose

frequency of severe hypoglycaemia

insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp

weight

BMI-SDS

skin fold thickness

cholesterol

adiponectin

Minimum age: 10 Years. Maximum age: 18 Years. Gender(s): Both.

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

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

Starting date: August 2003
Ending date: September 2005
Last updated: September 3, 2006