- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00598377
Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease
Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Istanbul, Turkey, 34390
- Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 2
Healthy subjects
|
1 microgram tetracosactin, intravenous injection, once for the test
Other Names:
|
Active Comparator: 1
Patients with autosomal dominant polycystic kidney disease
|
1 microgram tetracosactin, intravenous injection, once for the test
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Inadequate response to tetracosactin infusion
Time Frame: 30 and 60 minutes after the drug is administered
|
30 and 60 minutes after the drug is administered
|
Collaborators and Investigators
Sponsor
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
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Joint Diseases
- Musculoskeletal Diseases
- Muscular Diseases
- Musculoskeletal Abnormalities
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Kidney Diseases
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Arthrogryposis
- Physiological Effects of Drugs
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Cosyntropin
Other Study ID Numbers
- 2007/233
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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