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:

Genetics Home Reference related topics: 17 alpha-hydroxylase/17,20-lyase deficiency 21-hydroxylase deficiency 3-beta-hydroxysteroid dehydrogenase deficiency congenital adrenal hyperplasia due to 11-beta-hydroxylase deficiency

MedlinePlus related topics: Steroids

Drug Information available for: Pioglitazone Pioglitazone hydrochloride

Genetic and Rare Diseases Information Center resources: 21-hydroxylase Deficiency Congenital Adrenal Hyperplasia Hyperadrenalism

U.S. FDA Resources

Further study details as provided by Radboud University:

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
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


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

Additional relevant MeSH terms:


Hyperplasia 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 Pioglitazone Hypoglycemic Agents Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 26, 2017

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