Blood Pressure Response to Sodium in the Diet
Primary Purpose
Hypertension
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High sodium diet and low sodium diet
Sponsored by

About this trial
This is an interventional diagnostic trial for Hypertension focused on measuring blood pressure, hypertension, salt sensitivity
Eligibility Criteria
Inclusion Criteria:
- Ages 18-70 (inclusive)
- Sex Male and female
- Race Caucasian and African-American/black
- BMI 18.-0-29.9
- BP Normal
Exclusion Criteria:
- hypertension
- blood pressure > 140/90 mmHg
Sites / Locations
- University of VirginiaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High sodium diet and low sodium diet
Arm Description
Each subject experiences both a high sodium and a low sodium diet.
Outcomes
Primary Outcome Measures
Blood pressure; Change in Mean Arterial Pressure from low salt diet to high salt diet
The mean arterial pressure that will determine salt sensitivity will be assessed during the last day of the diet week. The study will be stopped for any individual during any visit if there is an average blood pressure of >180/114 mmHg.
Secondary Outcome Measures
Urine sodium
Genetic analysis for specified genes associated with hypertension
Full Information
NCT ID
NCT01899495
First Posted
January 22, 2013
Last Updated
October 14, 2016
Sponsor
University of Virginia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
1. Study Identification
Unique Protocol Identification Number
NCT01899495
Brief Title
Blood Pressure Response to Sodium in the Diet
Official Title
D1 and AT1 Receptor Interaction in Human Hypertension: Sodium Sensitivity of Blood Pressure
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
January 2005 (undefined)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
August 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Previous studies have demonstrated that single nucleotide polymorphisms (SNPs) of the sodium-bicarbonate co-transporter gene (SLC4A5) are associated with hypertension. We tested the hypothesis that SNPs in SLC4A5 are associated with salt sensitivity of blood pressure in 185 whites consuming an isocaloric constant diet with a randomized order of 7 days of low sodium (Na+) and 7 days of high Na+ intake. Salt sensitivity was defined as a ≥7-mm Hg increase in mean arterial pressure during a randomized transition between low and high Na+ diet.
A total of 35 polymorphisms in 17 candidate genes were assayed, 25 of which were tested for association. Association analyses with salt sensitivity revealed 3 variants that associated with salt sensitivity. Of these, 2 SNPs in SLC4A5 (rs7571842 and rs10177833) demonstrated highly significant results and large effects sizes, using logistic regression. These 2 SNPs had P values of 1.0×10-4 and 3.1×10-4 with odds ratios of 0.221 and 0.221 in unadjusted regression models, respectively, with the G allele at both sites conferring protection. These SNPs remained significant after adjusting for body mass index and age (P=8.9×10-5 and 2.6×10-4 and odds ratios 0.210 and 0.286, respectively). Furthermore, the association of these SNPs with salt sensitivity was replicated in a second hypertensive population. Meta-analysis demonstrated significant associations of both SNPs with salt sensitivity (rs7571842 [P=1.2×10-5]; rs1017783 [P=1.1×10-4]).
In conclusion, SLC4A5 variants are strongly associated with salt sensitivity of blood pressure in 2 separate white populations.
Detailed Description
Subjects are placed on an isocaloric diet, one week with high sodium(300mEq) and one week with low sodium(10mEq), in randomized order. Twenty-four hour urine sodium and urine creatinine levels verify diet compliance. Blood pressure measurements are recorded during each diet week by automated blood pressure monitoring system. Each blood pressure is taken in the right arm 3 times while the subject is sitting quietly for 45 minutes .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
blood pressure, hypertension, salt sensitivity
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
High sodium diet and low sodium diet
Arm Type
Experimental
Arm Description
Each subject experiences both a high sodium and a low sodium diet.
Intervention Type
Other
Intervention Name(s)
High sodium diet and low sodium diet
Intervention Description
Isocaloric diet with 60 mEq of potassium and 1gm protein/kg body weight with high sodium 300mEq; low sodium 10 mEq.
Primary Outcome Measure Information:
Title
Blood pressure; Change in Mean Arterial Pressure from low salt diet to high salt diet
Description
The mean arterial pressure that will determine salt sensitivity will be assessed during the last day of the diet week. The study will be stopped for any individual during any visit if there is an average blood pressure of >180/114 mmHg.
Time Frame
Study subjects will be observed 5 times during the 2 week intervention
Secondary Outcome Measure Information:
Title
Urine sodium
Time Frame
Urine chemistry analysis will be assessed from a 24-hour urine collection on the last day of each diet week.
Title
Genetic analysis for specified genes associated with hypertension
Time Frame
During the screening visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Ages 18-70 (inclusive)
Sex Male and female
Race Caucasian and African-American/black
BMI 18.-0-29.9
BP Normal
Exclusion Criteria:
hypertension
blood pressure > 140/90 mmHg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Carey, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mahabuba Akhter, M.B.B.S, MS
Phone
434-924-8757
Email
SaltSensitivityStudy@email.virginia.edu
First Name & Middle Initial & Last Name & Degree
Robert M Carey, MD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
Citation
http://hyper.ahajournals.org/content/early/2012/09/17/HYPERTENSIONAHA.112.196071.full.pdf
Results Reference
result
Learn more about this trial
Blood Pressure Response to Sodium in the Diet
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