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Rosiglitazone and Insulin in T1DM Adolescents

This study has been completed.
Sponsor:
Collaborators:
Sydney Children's Hospital, Randwick
National Health and Medical Research Council, Australia
Novo Nordisk A/S
Information provided by:
The University of New South Wales
ClinicalTrials.gov Identifier:
NCT00372086
First received: September 3, 2006
Last updated: NA
Last verified: September 2006
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Type 1 Diabetes
Puberty: >Tanner 2 Breast Development or Testis >4ml
Drug: Rosiglitazone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: The Addition of Rosiglitazone to Insulin in Adolescents With Type 1 Diabetes and Poor Glycaemic Control: a Randomized, Placebo Controlled Trial

Resource links provided by NLM:


Further study details as provided by The University of New South Wales:

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

Estimated Enrollment: 32
Study Start Date: August 2003
Estimated Study Completion Date: September 2005
  Eligibility

Ages Eligible for Study:   10 Years to 18 Years
Genders Eligible for Study:   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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00372086

Locations
Australia, New South Wales
Sydney Children's Hospital
Sydney, New South Wales, Australia, 2038
Sponsors and Collaborators
The University of New South Wales
Sydney Children's Hospital, Randwick
National Health and Medical Research Council, Australia
Novo Nordisk A/S
Investigators
Principal Investigator: Monique Stone, MBBS FRACP Royal North Shore Hospital
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00372086     History of Changes
Other Study ID Numbers: 02/315, JHH ethics: 04/02/11/3.04, CHW ethics: 2003/037
Study First Received: September 3, 2006
Last Updated: September 3, 2006
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Autoimmune Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Immune System Diseases
Metabolic Diseases
Rosiglitazone
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014