Clinical Trials Directory

Trials / Completed

CompletedNCT03696433

Visualizing Vascular Mechanisms of Salt Sensitivity

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Vanderbilt University Medical Center · Academic / Other
Sex
All
Age
18 Years – 55 Years
Healthy volunteers
Accepted

Summary

This study aims to assess the salt sensitive blood pressure response to dietary salt load compared with radiological markers of salt handling.

Detailed description

Hypertension is a major cause of heart disease, heart failure, and stroke. Hypertension, or high blood pressure, affects people differently and is related to the body's ability to maintain healthy circulation of salt. Some individuals may be affected by salt sensitive blood pressure (SSBP), when their blood pressure changes in response to dietary salt load. SSBP is a prevalent, independent risk factor for developing cardiovascular disease that preferentially affects black individuals. Current methods to assess SSBP require dietary salt loading over the course of days to weeks, and measurement of blood pressure following high salt diet and low salt diet. Such lengthy protocols are not feasible in a clinical setting to evaluate this risk factor for cardiovascular disease, and more importantly, these procedures provide incomplete information about mechanisms of salt sensitivity. Our knowledge regarding salt handling in the body is limited. While renal dysfunction is partly responsible for SSBP, recent research points to the role of lymphatic vascular clearance in regulating tissue salt storage and blood pressure control. To better understand these mechanisms in vivo, we have recently developed a noninvasive magnetic resonance (MR) lymphangiography method sensitive to lymphatic vasculature, and applied standardized MR protocols for measuring tissue sodium and fat storage in adults with impaired lymphatic clearance. We found evidence of lymph stasis and tissue salt deposition that correlated with local subcutaneous fat volume. Here, we will test whether similar lymphatic pathways are impaired in persons with SSBP, leading to tissue salt and fat storage, in comparison to the involvement of renal dysfunction in SSBP tissue profiles. The aims of this study are to improve our understanding of vascular mechanisms of human salt storage, and to provide standardized radiologic biomarkers sensitive to the SSBP phenotype. This study will test the primary hypothesis that the SSBP response is correlated with baseline tissue sodium storage, and elevated in persons with salt sensitivity. Secondary hypotheses will address whether the SSBP response is related to fat storage, lymphatic vascular function, renal vascular function, and impaired target organ responses to salt loading, including decreased urinary sodium excretion, and less suppression of plasma renin and serum aldosterone.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTLow-salt dietThe low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
DIETARY_SUPPLEMENTHigh-salt dietThe high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.

Timeline

Start date
2019-02-01
Primary completion
2022-11-04
Completion
2022-11-04
First posted
2018-10-04
Last updated
2025-01-15
Results posted
2025-01-15

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03696433. Inclusion in this directory is not an endorsement.