The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension

Sponsor

Regional Hospital Holstebro (Other)

Overall Status

Completed

CT.gov ID

NCT00345124

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

that the function and/or regulation of AQP2 and/or ENaC in the principal cells is abnormal in essential hypertension.
if an abnormal function of the principal cells is present in essential hypertension, this will become more pronounced at high and low sodium intake.

Condition or Disease	Intervention/Treatment	Phase
Essential Hypertension and Healthy Controls	Behavioral: high sodium diet Behavioral: Low Sodium Diet	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Double (Participant, Investigator)

Official Title:

The Effect of High and Low Sodium Intake on Urinary Aquaporin-2 in Essential Hypertension, During Basal Conditions and After Hypertonic Saline Infusion.

Study Start Date :

May 1, 2006

Actual Primary Completion Date :

May 1, 2009

Actual Study Completion Date :

Aug 1, 2009

Outcome Measures

Primary Outcome Measures

u-AQP-2 [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]
fractional sodium excretion [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]
p-vasopressin [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]
p-aldosterone [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]

Secondary Outcome Measures

u-p-AQP-2 [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]
u-ENaC(alfa,beta,gamma) [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.]
uPGE2 [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]
GFR [Before and after hypertonic saline infusion after 4 days on high and low sodium diet, respectively.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Caucasian men and women
Age 18-65 years
Arterial hypertension
Body mass index between 18.5 and 30 kg/m2

Exclusion Criteria:

Secondary hypertension
Isolated systolic hypertension
History or clinical signs of AMI, atrial fibrillation, disease of the heart valves, or chronic heart failure.
Malignant disease
Prior apoplexy
alcohol or drug abuse
Drug use except antihypertensives and oral contraceptives
Abnormal biochemical screening of the blood regarding: red and white blood count, s-creatinine (> 200 micromol/L), b-hemoglobin, p-Sodium, p- potassium, p-albumine, p-bilirubin, p-alanine aminotransferase, p-alkaline phosphatase, p-cholesterol and b-glucose.
Abnormal screening of the urine regarding: Blood, albumine and glucose.
abnormal electrocardiogram
Blood donation within one month of the first examination day
Unwillingness to participate

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	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