Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

February 17, 2009 updated by: Istanbul University

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.

Study Overview

Status

Completed

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

Interventional

Enrollment (Actual)

49

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey, 34390
        • Istanbul Univetsity, Istanbul Medical Faculty, Department of Internal Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 56 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

September 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

December 31, 2007

First Submitted That Met QC Criteria

January 18, 2008

First Posted (Estimate)

January 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 19, 2009

Last Update Submitted That Met QC Criteria

February 17, 2009

Last Verified

February 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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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