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

Sponsor
University Hospital Inselspital, Berne (Other)
Overall Status
Completed
CT.gov ID
NCT01009229
Collaborator
(none)
100
Enrollment
1
Location
1
Arm
13
Duration (Months)
7.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: Low and high salt diets
 N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Reduced 11 Beta Hydroxysteroid Dehydrogenase 2 (11 Beta HSD2) Activity, a Novel Mechanism of Salt Sensitivity and Hypertension After Renal Allograft Donation?
Study Start Date :
Jun 1, 2009
Actual Primary Completion Date :
Jul 1, 2010
Actual Study Completion Date :
Jul 1, 2010

Arms and Interventions

Arm Intervention/Treatment
Other: 1

Dietary Supplement: Low and high salt diets
High salt diet: 150mmol/d Low salt diet: 30mmol/d
Other Names:
  • NaCl

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Salt sensitivity, arterial hypertension [day 0, 14, 52, 156, 208, yearly]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 70 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • acceptance for living kidney donation
    Exclusion Criteria:
    • withdrawal of consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of nephrology and hypertension, Universitiy of Bern Bern Switzerland 3010

    Sponsors and Collaborators

    • University Hospital Inselspital, Berne

    Investigators

    • Principal Investigator: Felix J Frey, Prof, University of Berne

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT01009229
    Other Study ID Numbers:
    • Uehlinger-001
    First Posted:
    Nov 6, 2009
    Last Update Posted:
    May 25, 2011
    Last Verified:
    May 1, 2011
    Additional relevant MeSH terms:
    Renal Insufficiency
    Hypertension

    Study Results

    No Results Posted as of May 25, 2011