Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

Sponsor

Istanbul University (Other)

Overall Status

Completed

CT.gov ID

NCT00598377

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

4.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: Tetracosactin	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

49 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Study Start Date :

Sep 1, 2006

Actual Primary Completion Date :

Sep 1, 2007

Actual Study Completion Date :

Sep 1, 2007

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Patients with autosomal dominant polycystic kidney disease	Drug: Tetracosactin 1 microgram tetracosactin, intravenous injection, once for the test Other Names: Synacthen
Active Comparator: 2 Healthy subjects	Drug: Tetracosactin 1 microgram tetracosactin, intravenous injection, once for the test Other Names: Synacthen

Arm

Intervention/Treatment

Active Comparator: 1

Patients with autosomal dominant polycystic kidney disease

Drug: Tetracosactin

1 microgram tetracosactin, intravenous injection, once for the test

Other Names:

Synacthen

Active Comparator: 2

Healthy subjects

Drug: Tetracosactin

1 microgram tetracosactin, intravenous injection, once for the test

Other Names:

Synacthen

Outcome Measures

Primary Outcome Measures

Inadequate response to tetracosactin infusion [30 and 60 minutes after the drug is administered]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 56 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine	Istanbul		Turkey	34390

Sponsors and Collaborators

Istanbul University

Investigators

Principal Investigator: Tevfik Ecder, Professor, Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology
Study Director: Fatih Tufan, Fellow, Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Study Director: Neşe Çolak, Professor, Istanbul University Istanbul Medical Faculty Department of Internal Medicine Division of Endocrinology
Study Chair: Bora Uslu, Fellow, Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Kültigin Türkmen, Fellow, Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Mükremin Uysal, Fellow, Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Study Chair: Nilüfer Alpay, Fellow, Istanbul University Istanbul Medical Faculty Department of Internal Medicine
Study Director: Rian Dişçi, Professor, Istanbul University Istanbul Medical Faculty Department of Public Health
Study Chair: Bledi Çerkezi, Fellow, Istanbul University Istanbul Medical Faculty Department of Radiology