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Effects of Pioglitazone in Congenital Adrenal Hyperplasia

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ClinicalTrials.gov Identifier: NCT00151710
Recruitment Status : Completed
First Posted : September 9, 2005
Last Update Posted : March 1, 2007
Sponsor:
Information provided by:
Radboud University

Study Description
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Brief Summary:
Congenital adrenal hyperplasia, an autosomal recessive condition, is mainly caused by mutations in the gene 21-hydroxylase and is treated with glucocorticoids in a slightly supraphysiological dose. Adult patients seem to be characterized by insulin resistance, which may be caused by the glucocorticoids and/or the accompanying obesity. The hypothesis of this study is that pioglitazone can improve insulin sensitivity and correlated cardiovascular risk factors in this specific group of patients. This will be tested in a randomized, placebo-controlled, cross-over trial; insulin sensitivity will be quantified by euglycemic hyperinsulinemic clamp studies.

Condition or disease Intervention/treatment Phase
Congenital Adrenal Hyperplasia Drug: Pioglitazone Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Official Title: Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • biochemical and genetically proven congenital adrenal hyperplasia
  • stable corticosteroid replacement for 3 months

Exclusion Criteria:

  • age < 18 years
  • inability to give informed consent
  • significant cardiovascular disease, defined as myocardial infarction or stroke, six months preceding the study
  • significant renal disease, GFR < 30 ml/min
  • significant liver disease, defined as more than 3 times upper limit of normal values of alanine aminotransferase (ALT) and aspartate aminotransferase (AST)
  • pregnancy
  • mental disease
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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 ClinicalTrials.gov identifier (NCT number): NCT00151710


Locations
Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Cornelis J Tack, MD, PhD Radboud University
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00151710     History of Changes
Other Study ID Numbers: H6E-UT-O013
First Posted: September 9, 2005    Key Record Dates
Last Update Posted: March 1, 2007
Last Verified: February 2007

Additional relevant MeSH terms:
Hyperplasia
Adrenal Hyperplasia, Congenital
Adrenogenital Syndrome
Adrenocortical Hyperfunction
Pathologic Processes
Disorders of Sex Development
Urogenital Abnormalities
Congenital Abnormalities
Genetic Diseases, Inborn
 Steroid Metabolism, Inborn Errors
Metabolism, Inborn Errors
Metabolic Diseases
Adrenal Gland Diseases
Endocrine System Diseases
Gonadal Disorders
Pioglitazone
Hypoglycemic Agents
Physiological Effects of Drugs