Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease - Full Text View

Sponsor:	Istanbul University
Information provided by:	Istanbul University
ClinicalTrials.gov Identifier:	NCT00598377

Purpose

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	Intervention
Autosomal Dominant Polycystic Kidney Disease	Drug: Tetracosactin

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Open Label, Active Control, Parallel Assignment
Official Title:	Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:

Genetics Home Reference related topics: polycystic kidney disease

Drug Information available for: Epinephrine bitartrate Epinephrine Cosyntropin

U.S. FDA Resources

Further study details as provided by Istanbul University:

Primary Outcome Measures:

Inadequate response to tetracosactin infusion [ Time Frame: 30 and 60 minutes after the drug is administered ] [ Designated as safety issue: No ]

Enrollment:	49
Study Start Date:	September 2006
Study Completion Date:	September 2007
Primary Completion Date:	September 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Patients with autosomal dominant polycystic kidney disease	Drug: Tetracosactin 1 microgram tetracosactin, intravenous injection, once for the test
2: Active Comparator Healthy subjects	Drug: Tetracosactin 1 microgram tetracosactin, intravenous injection, once for the test

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

Ages Eligible for Study:	20 Years to 56 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00598377

Locations

Turkey
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

More Information

No publications provided

Responsible Party:	Istanbul University, Istanbul Medical Faculty, Division of Nephrology ( Tevfik Ecder )
Study ID Numbers:	2007/233, 2007/233
Study First Received:	December 31, 2007
Last Updated:	February 17, 2009
ClinicalTrials.gov Identifier:	NCT00598377 History of Changes
Health Authority:	Turkey: Ethics Committee

Keywords provided by Istanbul University:

Autosomal dominant polycystic kidney disease
Adrenal functions
Renal volume
Glomerular filtration rate
Adrenal Cortex Function Tests

Additional relevant MeSH terms:

Urologic Diseases
Polycystic Kidney, Autosomal Dominant
Physiological Effects of Drugs
Kidney Diseases, Cystic
Hormones, Hormone Substitutes, and Hormone Antagonists

Polycystic Kidney Diseases
Cosyntropin
Kidney Diseases
Hormones
Pharmacologic Actions

ClinicalTrials.gov processed this record on February 08, 2010