Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

Autosomal Dominant Polycystic Kidney Disease Clinical Trial

Official title:

Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00598377
• Other study ID #: 2007/233
• Secondary ID: 2007/233
• Status: Completed
• Phase: N/A
• First received: December 31, 2007
• Last updated: February 17, 2009
• Start date: September 2006
• Est. completion date: September 2007

Study information

• Verified date: February 2008
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

We aimed to evaluate the hypothalamus-pituitary-adrenal axis in autosomal dominant polycystic kidney disease (ADPKD) patients. Twenty two ADPKD patients and 27 healthy subjects were enrolled.

Description:

CONTEXT: Autosomal dominant polycystic kidney disease (ADPKD) is the most common hereditary kidney disease and extrarenal manifestations may be observed in many organ systems. Hypothalamus-pituitary-adrenal axis in patients with ADPKD was not evaluated extensively.

OBJECTIVE: We aimed to evaluate the hypothalamus-pituitary-adrenal axis in ADPKD patients.

METHODS: Twenty two ADPKD patients and 27 healthy subjects were enrolled. Basal dehydroepiandrosterone-sulfate (DHEAS) levels and cortisol and dehydroepiandrosterone responses to low dose short adrenocorticotropin stimulation test were assessed. Correlation analyses of these parameters with glomerular filtration rates, renal volumes and pain characteristics in patients with ADPKD were done.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2007
• Est. primary completion date: September 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 56 Years

Eligibility

Inclusion Criteria:

• Healthy subjects

• Diagnosis of autosomal dominant polycystic kidney disease

Exclusion Criteria:

• A glomerular filtration rate below 60 ml/min

• History of recent major surgery

• Systemic infections with fever

• Significant hirsutism (Ferriman Gallwey score=8)

• Congenital adrenal hyperplasia

• Late onset congenital adrenal hyperplasia

• Systemic corticosteroid use (including previous use)

• Topical corticosteroid use

• Menstrual irregularity

• History of thromboembolism

• Uncontrolled diabetes or hypertension

• History of psychosis

• Pregnancy

• Lactation

• History of hypersensitivity to tetracosactin

Related Conditions & MeSH terms

• Autosomal Dominant Polycystic Kidney Disease
• Kidney Diseases
• Polycystic Kidney Diseases
• Polycystic Kidney, Autosomal Dominant

Intervention

Drug:
• Tetracosactin
1 microgram tetracosactin, intravenous injection, once for the test

Locations

Country	Name	City	State
Turkey	Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inadequate response to tetracosactin infusion		30 and 60 minutes after the drug is administered