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The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Autosomal Dominant Polycystic Kidney Disease

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regional Hospital Holstebro
ClinicalTrials.gov Identifier:
NCT00410007
First received: December 10, 2006
Last updated: December 4, 2011
Last verified: December 2011
History of Changes
  Purpose

The aim of the study is to test the following hypotheses:

  1. that the function and/or regulation of AQP2 and /or ENaC in the principal cells is abnormal in autosomal dominant polycystic kidney disease.
  2. if an abnormal function of the principal cells is present in autosomal dominant polycystic kidney disease, this woll become more pronounced at high and low sodium intake.

Condition Intervention
Polycystic Kidney, Autosomal Dominant
 Behavioral: High Sodium Diet
Behavioral: Low Sodium Diet

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Official Title: The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Autosomal Dominant Polycystic Kidney Disease, During Basal Conditions and After Hypertonic Saline Infusion.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Regional Hospital Holstebro:

Primary Outcome Measures:
  • u-AQP-2; fractional sodium excretion, p-vasopressin; p-aldosterone. [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • u-p-AQP-2; u-ENaC (alpha, beta, gamma); CH2O; u-cAMP; uPGE-2, GFR. [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ] [ Designated as safety issue: No ]

Enrollment: 29
Study Start Date: October 2006
Study Completion Date: November 2011
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: High Sodium Diet
    250-350 mmol
    Behavioral: Low Sodium Diet
    25-35 mmol
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Caucasian men and women
  • age 18-65 years
  • BMI between 18,5-30,0 kg/m2

  • ADPKD, diagnosed by the following findings on ultra scan:

    • for patients without ADPKD family history: > 5 bilateral cysts
    • for patients with ADPKD family history: < 30 years: 2 cysts (unilateral or bilateral) 30-60 years: 2 or more bilateral cysts > 60 years: 4 or more bilateral cysts
  • Kidney function: stadium 1-4.

Exclusion Criteria:

  • Other kidney disease
  • Anamnestic or clinical signs of acute myocardial infarction, atrial fibrillation, heart valve disease or chronic heart failure
  • Anamnestic or clinical signs of disease in lungs, liver,endocrine organs or brain or neoplastic disease
  • Family history of rupture of intracerebral aneurisms
  • Alcohol or drug abuse
  • Smoking
  • Medical treatment arat form antihypertensives and oral anticonceptives
  • Pregnancy or breastfeeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00410007

Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Regional Hospital Holstebro
Investigators
Study Chair: Erling B. Pedersen, Professor Department of Medical Research, Holstebro Hospital, Denmark
Principal Investigator: Carolina C. Graffe, MD Department of Medical Research, Holstebro Hospital, Denmark
  More Information

No publications provided

Responsible Party: Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT00410007     History of Changes
Other Study ID Numbers: med.res.hos.2006.cc.03
Study First Received: December 10, 2006
Last Updated: December 4, 2011
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Regional Hospital Holstebro:
ADPKD
Urinary Aquaporin-2
ENaC
Fractional sodium excretion
High/low sodium diet

Additional relevant MeSH terms:
Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on May 19, 2013