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Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

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ClinicalTrials.gov Identifier: NCT00598377
Recruitment Status : Completed
First Posted : January 21, 2008
Last Update Posted : February 19, 2009
Sponsor:
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment
Autosomal Dominant Polycystic Kidney Disease Drug: Tetracosactin

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 49 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Assessment of Adrenal Functions in Patients With Autosomal Dominant Polycystic Kidney Disease
Study Start Date : September 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. Inadequate response to tetracosactin infusion [ Time Frame: 30 and 60 minutes after the drug is administered ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 56 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: January 21, 2008    Key Record Dates
Last Update Posted: February 19, 2009
Last Verified: February 2008

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
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Epinephrine
Racepinephrine
Epinephryl borate
Cosyntropin
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists