Blood Pressure Response to Sodium in the Diet
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01899495|
Recruitment Status : Recruiting
First Posted : July 15, 2013
Last Update Posted : October 18, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Hypertension||Other: High sodium diet and low sodium diet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||D1 and AT1 Receptor Interaction in Human Hypertension: Sodium Sensitivity of Blood Pressure|
|Study Start Date :||January 2005|
|Estimated Primary Completion Date :||August 2021|
|Estimated Study Completion Date :||August 2021|
Experimental: High sodium diet and low sodium diet
Each subject experiences both a high sodium and a low sodium diet.
Other: High sodium diet and low sodium diet
Isocaloric diet with 60 mEq of potassium and 1gm protein/kg body weight with high sodium 300mEq; low sodium 10 mEq.
- Blood pressure; Change in Mean Arterial Pressure from low salt diet to high salt diet [ Time Frame: Study subjects will be observed 5 times during the 2 week intervention ]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.
- Urine sodium [ Time Frame: Urine chemistry analysis will be assessed from a 24-hour urine collection on the last day of each diet week. ]
- Genetic analysis for specified genes associated with hypertension [ Time Frame: During the screening visit ]
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): NCT01899495
|United States, Virginia|
|University of Virginia||Recruiting|
|Charlottesville, Virginia, United States, 22903|
|Contact: Mahabuba Akhter, M.B.B.S, MS 434-924-8757 SaltSensitivityStudy@email.virginia.edu|
|Principal Investigator: Robert M Carey, MD|
|Principal Investigator:||Robert M Carey, MD||University of Virginia|