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Effects of Pioglitazone in Congenital Adrenal Hyperplasia

This study has been completed.
Information provided by:
Radboud University Identifier:
First received: September 8, 2005
Last updated: February 28, 2007
Last verified: February 2007
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 Intervention
Congenital Adrenal Hyperplasia
Drug: Pioglitazone

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

Resource links provided by NLM:

Further study details as provided by Radboud University:


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its identifier: NCT00151710

Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands, 6500 HB
Sponsors and Collaborators
Radboud University
Principal Investigator: Cornelis J Tack, MD, PhD Radboud University
  More Information Identifier: NCT00151710     History of Changes
Other Study ID Numbers: H6E-UT-O013
Study First Received: September 8, 2005
Last Updated: February 28, 2007

Additional relevant MeSH terms:
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
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on April 25, 2017