Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: Tetracosactin	Not Applicable

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Actual Primary Completion Date :	September 2007
Actual Study Completion Date :	September 2007

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Primary Outcome Measures :

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

Eligibility Criteria

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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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations 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
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