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

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ClinicalTrials.gov Identifier: NCT00410007
Recruitment Status : Completed
First Posted : December 12, 2006
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Carolina Cannillo, Regional Hospital Holstebro

Brief Summary:

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 will become more pronounced at high and low sodium intake.

Condition or disease Intervention/treatment Phase
Polycystic Kidney, Autosomal Dominant Behavioral: High Sodium Diet Behavioral: Low Sodium Diet Behavioral: Hypertonic saline infusion Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 29 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
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.
Study Start Date : October 2006
Actual Primary Completion Date : October 2010
Actual Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
U.S. FDA Resources

Arm Intervention/treatment
Patients with ADPKD, HS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
Behavioral: High Sodium Diet
250-350 mmol
Behavioral: Hypertonic saline infusion
7 ml/ kg of 3% saline were given over 30 minutes.
Patients with ADPKD, LS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
Behavioral: Low Sodium Diet
25-35 mmol
Behavioral: Hypertonic saline infusion
7 ml/ kg of 3% saline were given over 30 minutes.
Healthy Control Subjects, HS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
Behavioral: High Sodium Diet
250-350 mmol
Behavioral: Hypertonic saline infusion
7 ml/ kg of 3% saline were given over 30 minutes.
Healthy Control Subjects, LS
Each subject was studied on 2 separate days at least 3 weeks apart. During 4 days before the study day, the subjects consumed either a high sodium diet or a low sodium diet in randomized order (HS-LS/ LS-HS). On the study day a hypertonic saline infusion was given.
Behavioral: Low Sodium Diet
25-35 mmol
Behavioral: Hypertonic saline infusion
7 ml/ kg of 3% saline were given over 30 minutes.



Primary Outcome Measures :
  1. u-AQP-2CR [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    Urinary Aquaporin-2 corrected for creatinine


Secondary Outcome Measures :
  1. u-ENaC (beta)CR [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    Urinary ENaC (beta) corrected for creatinine

  2. FENa [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    fractional sodium excretion

  3. CH2O [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    Free water excretion

  4. u-cAMP [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    urinary excretion of cAMP

  5. uPGE-2 [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    urinary excretion of PGE-2

  6. GFR [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    glomerular filtration rate

  7. p-vasopressin [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    plasma concentration of vasopressin

  8. p-aldosterone. [ Time Frame: Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively. ]
    plasma concentration of aldosterone



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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00410007


Locations
Denmark
Department of Medical Research, Holstebro Hospital
Holstebro, Denmark, 7500
Sponsors and Collaborators
Carolina Cannillo
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

Responsible Party: Carolina Cannillo, Principal Investigator, PhD, MD, Regional Hospital Holstebro
ClinicalTrials.gov Identifier: NCT00410007     History of Changes
Other Study ID Numbers: med.res.hos.2006.cc.03
First Posted: December 12, 2006    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018

Keywords provided by Carolina Cannillo, 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
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn