Effects of Pioglitazone in Congenital Adrenal Hyperplasia

Not Applicable

Completed

• Conditions: Congenital Adrenal Hyperplasia

• Registration Number: NCT00151710
• Lead Sponsor: Radboud University Medical Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2005-09-08
• Study First Submitted QC: 2005-09-08
• Study First Posted: 2005-09-09
• Status Verified: 2007-02
• Last Update Submitted: 2007-02-28
• Last Update Posted: 2007-03-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Trial Locations

Locations (1)

Radboud University Nijmegen Medical Centre; 🇳🇱 Nijmegen, Gelderland, Netherlands