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

NCT00410007 | Completed

• 1 other identifier: med.res.hos.2006.cc.03
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

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

1. 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. 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.

Conditions

Polycystic Kidney, Autosomal Dominant

Keywords

ADPKD; Urinary Aquaporin-2; ENaC; Fractional sodium excretion; High/low sodium diet

Outcome Measures

Primary Outcomes (1)

• u-AQP-2CR

  Urinary Aquaporin-2 corrected for creatinine

  Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Secondary Outcomes (8)

• u-ENaC (beta)CR

  Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

• FENa

  Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

• CH2O

  Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

• u-cAMP

  Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

• uPGE-2

  Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.

Study Arms (4)

Patients with ADPKD, HS

OTHER

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; Behavioral: Hypertonic saline infusion

Patients with ADPKD, LS

OTHER

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; Behavioral: Hypertonic saline infusion

Healthy Control Subjects, HS

OTHER

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; Behavioral: Hypertonic saline infusion

Healthy Control Subjects, LS

OTHER

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; Behavioral: Hypertonic saline infusion

Interventions

High Sodium Diet BEHAVIORAL

250-350 mmol

Healthy Control Subjects, HS; Patients with ADPKD, HS

Low Sodium Diet BEHAVIORAL

25-35 mmol

Healthy Control Subjects, LS; Patients with ADPKD, LS

Hypertonic saline infusion BEHAVIORAL

7 ml/ kg of 3% saline were given over 30 minutes.

Healthy Control Subjects, HS; Healthy Control Subjects, LS; Patients with ADPKD, HS; Patients with ADPKD, LS

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Carolina Cannillo: lead

Study Sites (1)

Department of Medical Research, Holstebro Hospital

Holstebro, 7500, Denmark

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Study Officials

• Erling B. Pedersen, Professor

  Department of Medical Research, Holstebro Hospital, Denmark

  STUDY CHAIR

• Carolina C. Graffe, MD

  Department of Medical Research, Holstebro Hospital, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator, PhD, MD

Study Record Dates

• First Submitted: December 10, 2006
• First Posted: December 12, 2006
• Study Start: October 1, 2006
• Primary Completion: October 1, 2010
• Study Completion: November 1, 2011
• Last Updated: March 20, 2018

Record last verified: 2018-03

Locations

DK (1)