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

December 31, 2007
February 17, 2009
September 2006
September 2007   (final data collection date for primary outcome measure)
Inadequate response to tetracosactin infusion [ Time Frame: 30 and 60 minutes after the drug is administered ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00598377 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease

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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Autosomal Dominant Polycystic Kidney Disease
Drug: Tetracosactin
1 microgram tetracosactin, intravenous injection, once for the test
Other Name: Synacthen
  • Active Comparator: 1
    Patients with autosomal dominant polycystic kidney disease
    Intervention: Drug: Tetracosactin
  • Active Comparator: 2
    Healthy subjects
    Intervention: Drug: Tetracosactin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
49
September 2007
September 2007   (final data collection date for primary outcome measure)

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
Both
20 Years to 56 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Turkey
 
NCT00598377
2007/233, 2007/233
No
Tevfik Ecder, Istanbul University, Istanbul Medical Faculty, Division of Nephrology
Istanbul University
Not Provided
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
Istanbul University
February 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP