Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

This study has been completed.
Sponsor:
Information provided by:
Istanbul University
ClinicalTrials.gov Identifier:
NCT00598377
First received: December 31, 2007
Last updated: February 17, 2009
Last verified: February 2008
  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: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease

Resource links provided by NLM:


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

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
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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: Tevfik Ecder, Istanbul University, Istanbul Medical Faculty, Division of Nephrology
ClinicalTrials.gov Identifier: NCT00598377     History of Changes
Other Study ID Numbers: 2007/233, 2007/233
Study First Received: December 31, 2007
Last Updated: February 17, 2009
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:
Kidney Diseases
Multicystic Dysplastic Kidney
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Congenital Abnormalities
Kidney Diseases, Cystic
Urogenital Abnormalities
Urologic Diseases
Cosyntropin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 21, 2014