Adrenal Functions in Autosomal Dominant Polycystic Kidney Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Autosomal Dominant Polycystic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

Patients with autosomal dominant polycystic kidney disease

Group Type ACTIVE_COMPARATOR

Tetracosactin

Intervention Type DRUG

1 microgram tetracosactin, intravenous injection, once for the test

2

Healthy subjects

Group Type ACTIVE_COMPARATOR

Tetracosactin

Intervention Type DRUG

1 microgram tetracosactin, intravenous injection, once for the test

Interventions

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Tetracosactin

1 microgram tetracosactin, intravenous injection, once for the test

Intervention Type DRUG

Other Intervention Names

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Synacthen

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

56 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Istanbul University, Istanbul Medical Faculty, Division of Nephrology

Principal Investigators

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Tevfik Ecder, Professor

Role: PRINCIPAL_INVESTIGATOR

Istanbul University, Istanbul Medical Faculty, Department of Internal Medicine, Division of Nephrology