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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

September 8, 2005
September 9, 2005
March 1, 2007
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Complete list of historical versions of study NCT00151710 on ClinicalTrials.gov Archive Site
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Effects of Pioglitazone in Congenital Adrenal Hyperplasia
Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.
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.
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Interventional
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Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Congenital Adrenal Hyperplasia
Drug: Pioglitazone
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Netherlands
 
 
NCT00151710
H6E-UT-O013
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Radboud University
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Principal Investigator: Cornelis J Tack, MD, PhD Radboud University
Radboud University
February 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP