Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

Not Applicable

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease
• Interventions: Drug: Tetracosactin

• Registration Number: NCT00598377
• Lead Sponsor: Istanbul University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2006-09
• Primary Completion: 2007-09
• Study Completion: 2007-09
• Study First Submitted: 2007-12-31
• Study First Submitted QC: 2008-01-18
• Study First Posted: 2008-01-21
• Status Verified: 2008-02
• Last Update Submitted: 2009-02-17
• Last Update Posted: 2009-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	Tetracosactin	Healthy subjects
1	Tetracosactin	Patients with autosomal dominant polycystic kidney disease

Primary Outcome Measures

Name	Time	Method
Inadequate response to tetracosactin infusion	30 and 60 minutes after the drug is administered

Trial Locations

Locations (1)

Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine; 🇹🇷 Istanbul, Turkey