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

December 10, 2006
December 4, 2011
October 2006
October 2010   (final data collection date for primary outcome measure)
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 ]
u-AQP-2; fractional sodium excretion, p-vasopressin; p-aldosterone.
Complete list of historical versions of study NCT00410007 on ClinicalTrials.gov Archive Site
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 ]
u-p-AQP-2; u-ENaC (alpha, beta, gamma); CH2O; u-cAMP; uPGE-2, GFR.
Not Provided
Not Provided
 
The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Autosomal Dominant Polycystic Kidney Disease
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.

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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Polycystic Kidney, Autosomal Dominant
  • Behavioral: High Sodium Diet
    250-350 mmol
  • Behavioral: Low Sodium Diet
    25-35 mmol
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
29
November 2011
October 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT00410007
med.res.hos.2006.cc.03
No
Regional Hospital Holstebro
Regional Hospital Holstebro
Not Provided
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
Regional Hospital Holstebro
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP