Rosiglitazone and Insulin in T1DM Adolescents

The University of New South Wales

Status and phase: Completed; Phase 4

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

Treatments: Drug: Rosiglitazone

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00372086

02/315

CHW ethics: 2003/037

JHH ethics: 04/02/11/3.04

Details and patient eligibility

About

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.

Sex: All

Ages: 10 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind