A Reduced 11-b-HSD Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?

NCT ID: NCT01009229

Last Updated: 2011-05-25

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

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-07-31

Brief Summary

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Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation according to official guidelines. An assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.

Detailed Description

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Consecutive living-kidney donor candidates (n=100) will be recruited after being accepted for donation. The assessment of salt sensitivity, 11 beta HSD activity, 24 hour blood pressure, urine collection and physical exam will be performed prior nephrectomy and 14, 52, 156, 208 days post-nephrectomy.

Conditions

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Renal Failure Renal Transplantation Living Donors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Group Type OTHER

Low and high salt diets

Intervention Type DIETARY_SUPPLEMENT

High salt diet: 150mmol/d Low salt diet: 30mmol/d

Interventions

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Low and high salt diets

High salt diet: 150mmol/d Low salt diet: 30mmol/d

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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NaCl

Eligibility Criteria

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Inclusion Criteria

* acceptance for living kidney donation

Exclusion Criteria

* withdrawal of consent
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Insel Gruppe AG, University Hospital Bern

OTHER

Sponsor Role lead

Responsible Party

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University of Berne, Switzerland

Principal Investigators

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Felix J Frey, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Berne

Locations

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Department of nephrology and hypertension, Universitiy of Bern

Bern, Canton of Bern, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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Uehlinger-001

Identifier Type: -

Identifier Source: org_study_id

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