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Completed

NCT Number: NCT00372086

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.

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Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases Puberty: >Tanner 2 Breast Development or Testis >4ml

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sydney Children's Hospital

Sydney, New South Wales, 2038, Australia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

rosiglitazone

Drug

Primary outcomes

  1. HbA1c

Secondary outcomes

  1. insulin dose

  2. frequency of severe hypoglycaemia

  3. insulin sensitivity assessed by euglycaemic, hyperinsulinaemic clamp

  4. weight

  5. BMI-SDS

  6. skin fold thickness

  7. cholesterol

  8. adiponectin

Sponsors and collaborators

Lead sponsor

The University of New South Wales

Other

Collaborators

  • National Health and Medical Research Council, Australia
  • Novo Nordisk A/S
  • Sydney Children's Hospitals Network

Registry information

Official study title

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

Important dates

Study start
2003
Study completion
2005
First posted
Sep 6, 2006
Registry last updated
Sep 6, 2006

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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