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Rosiglitazone and Insulin in T1DM Adolescents

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00372086
Recruitment Status : Completed
First Posted : September 6, 2006
Last Update Posted : September 6, 2006
Sydney Children's Hospitals Network
National Health and Medical Research Council, Australia
Novo Nordisk A/S
Information provided by:
The University of New South Wales

Brief Summary:
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 or disease Intervention/treatment Phase
Type 1 Diabetes Puberty: >Tanner 2 Breast Development or Testis >4ml Drug: Rosiglitazone Phase 4

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Study Type : Interventional  (Clinical Trial)
Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
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
Study Start Date : August 2003
Study Completion Date : September 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Primary Outcome Measures :
  1. HbA1c

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00372086

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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 Hospitals Network
National Health and Medical Research Council, Australia
Novo Nordisk A/S
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Principal Investigator: Monique Stone, MBBS FRACP Royal North Shore Hospital

Layout table for additonal information Identifier: NCT00372086    
Other Study ID Numbers: 02/315
JHH ethics: 04/02/11/3.04
CHW ethics: 2003/037
First Posted: September 6, 2006    Key Record Dates
Last Update Posted: September 6, 2006
Last Verified: September 2006
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs