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NCT00151710 Clinical Trial

Effects of Pioglitazone in Congenital Adrenal Hyperplasia

Congenital Adrenal Hyperplasia Clinical Trial

Official title:
Effects of Pioglitazone in Glucocorticoid-Induced Insulin Resistance. Studies in Congenital Adrenal Hyperplasia.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00151710
Other study ID # H6E-UT-O013
Secondary ID
Status Completed
Phase N/A
First received September 8, 2005
Last updated February 28, 2007

Study information
Verified date February 2007
Source Radboud University
Contact n/a
Is FDA regulated No
Health authority Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double-Blind

Related Conditions & MeSH terms

Intervention

Drug:
• Pioglitazone

Locations
Country Name City State
Netherlands Radboud University Nijmegen Medical Centre Nijmegen Gelderland

Sponsors (1)
Lead Sponsor Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

See also
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Active, not recruiting NCT04544410 - A Ph2b to Evaluate Tildacerfont in the Reduction of Glucocorticoid Steroid Doses in Adult CAH Phase 2
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Recruiting NCT05687474 - Baby Detect : Genomic Newborn Screening
Enrolling by invitation NCT05162950 - Effects and Importance of Epinephrine/Adrenalin Deficiency in CAH
Withdrawn NCT03532022 - Open-label Comparison of Chronocort® Versus Standard Glucocorticoid Replacement Therapy Phase 3
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Completed NCT02934399 - Dynamic Hormone Diagnostics in Endocrine Disease
Recruiting NCT04903587 - Gonadal Changes In Congenital Adrenal Hyperplasia Patients
Not yet recruiting NCT04536662 - Comparisons of Different Forms of Glucocorticoid on the Recovery of Reproductive Function in Patients With 21α-hydroxylase Deficiency Phase 4
Recruiting NCT04463316 - GROWing Up With Rare GENEtic Syndromes
Active, not recruiting NCT04490915 - Global Safety and Efficacy Registration Study of Crinecerfont for Congenital Adrenal Hyperplasia Phase 3
Completed NCT01807364 - Cardiovascular Risk Profile in Patients With Congenital Adrenal Hyperplasia N/A
Completed NCT02804178 - A Study of ATR-101 for the Treatment of Congenital Adrenal Hyperplasia Phase 2
Completed NCT03019614 - An Open Label Study in Healthy Volunteers to Compare Chronocort® to Hydrocortisone Phase 1
Not yet recruiting NCT04293133 - Final Height in Patients With CAH
Recruiting NCT03897504 - Surgical Evaluation of Using the Prepuce in Feminizing Genitoplasty N/A
Recruiting NCT05663320 - A Study of a Virtual Education-Based Transition Intervention to Improve Transition Readiness in Adolescent and Young Adults With Congenital Adrenal Hyperplasia N/A
Active, not recruiting NCT04806451 - Global Safety and Efficacy Registration Study of Crinecerfont in Pediatric Patients With Classic Congenital Adrenal Hyperplasia (CAHtalyst Pediatric Study) Phase 3