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Effects of Pioglitazone in Congenital Adrenal Hyperplasia

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00151710
First received: September 8, 2005
Last updated: February 28, 2007
Last verified: February 2007
History of Changes
  Purpose

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:

U.S. FDA Resources

Further study details as provided by Radboud University:
  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00151710     History of Changes
Other Study ID Numbers: H6E-UT-O013
Study First Received: September 8, 2005
Last Updated: February 28, 2007
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

ClinicalTrials.gov processed this record on February 27, 2015