Clinical trial NCT00598377: Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
Official title: Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Autosomal Dominant Polycystic Kidney Disease
Keywords: Autosomal dominant polycystic kidney disease
Adrenal functions
Renal volume
Glomerular filtration rate
Adrenal Cortex Function Tests
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2008-01-21
Enrollment: 49
Sex: ALL
Minimum age (years): 20
Maximum age (years): 56
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Inadequate response to tetracosactin infusion
timeFrame: 30 and 60 minutes after the drug is administered
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine
Study officials:
affiliation: Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology
name: Tevfik Ecder, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Istanbul University Istanbul Medical Faculty Department of Internal Medicine
name: Fatih Tufan, Fellow
role: STUDY_DIRECTOR
affiliation: Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of Endocrinology
name: Neşe Çolak, Professor
role: STUDY_DIRECTOR
affiliation: Istanbul University Istanbul Medical Faculty Department of Internal Medicine
name: Bora Uslu, Fellow
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Medical Faculty Department of Internal Medicine
name: Kültigin Türkmen, Fellow
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Medical Faculty Department of Internal Medicine
name: Mükremin Uysal, Fellow
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Medical Faculty Department of Internal Medicine
name: Nilüfer Alpay, Fellow
role: STUDY_CHAIR
affiliation: Istanbul University Istanbul Medical Faculty Department of Public Health
name: Rian Dişçi, Professor
role: STUDY_DIRECTOR
affiliation: Istanbul University Istanbul Medical Faculty Department of Radiology
name: Bledi Çerkezi, Fellow
role: STUDY_CHAIR
References: