Visualizing Vascular Mechanisms of Salt Sensitivity

赞助:

合作者:

信息的提供 (责任方):

Rachelle Crescenzi，Vanderbilt University Medical Center

追踪信息

首次提交日期 ^ICMJE

September 25, 2018

首次发布日期e ^ICMJE

October 4, 2018

最后更新发布日期

October 4, 2018

预计研究开始日期 ^ICMJE

November 1, 2018

预计主要完成日期

February 28, 2021 (主要结果测量的最终数据收集日期)

目前主要观察指标 ^ICMJE

Change in Salt-sensitive blood pressure after low salt diet[ Time Frame: Following completion of all dietary supplements and washout, in no less than 21 days. ]

Measured as the difference in mean arterial pressure following high-salt diet compared to low-salt diet

原始主要观察测量 ^ICMJE

与当前相同

目前的二级观察 ^ICMJE

Tissue sodium content of the legs[ Time Frame: At baseline ]
Measured by sodium MRI
Fat fraction of the legs[ Time Frame: At baseline ]
Measured by conventional MRI, in units of fat/water volume ratio
Kidney blood perfusion rate[ Time Frame: At baseline ]
Measured by conventional noninvasive MRI
Lymphatic stasis of the legs[ Time Frame: At baseline ]
Measured by noninvasive MR lymphangiography
Urinary sodium excretion[ Time Frame: At baseline and each of 3 study visits occurring about every 7 days, to be completed in no less than 21 days. ]
Measured from 24-hour urine collection
Plasma renin[ Time Frame: At baseline and each of 3 study visits occurring about every 7 days, to be completed in no less than 21 days. ]
Physiological parameter
Serum aldosterone[ Time Frame: At baseline and each of 3 study visits occurring about every 7 days, to be completed in no less than 21 days. ]
Physiological parameter

描述性信息

简略标题 ^ICMJE

Visualizing Vascular Mechanisms of Salt Sensitivity

正式标题 ^ICMJE

Visualizing Vascular Mechanisms of Salt Sensitivity

简要概况

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

详细说明

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.

研究类型 ^ICMJE

Interventional

研究阶段

N/A

研究设计 ^ICMJE

分配: Randomized
干预模型: Crossover Assignment
干预模型描述:
盲法: Interventional
盲法描述:
主要目的: Basic Science

适用条件 ^ICMJE

干预项目 ^ICMJE

Dietary Supplement: Low-salt diet
The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.
Dietary Supplement: High-salt diet
The 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.

研究工具

Experimental: Low- then high-salt diet
10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.
Experimental: High- then low-salt diet
10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.

招募信息

招募状态 ^ICMJE

Not yet recruiting

预计入组 ^ICMJE

原始预计入组 ^ICMJE

与当前相同

预计研究完成日期

June 30, 2021

预计主要完成日期

February 28, 2021 (主要结果测量的最终数据收集日期)

合格标准 ^ICMJE

Inclusion Criteria: - Identification as black race - Age between 18 and 55 years - Body mass index between 25 and <35 kg/m2 - Normotensive or pre-hypertensive - Willing to adhere to study diets - Able to provide informed consent and communicate with study personnel Exclusion Criteria: - Prevalent cardiovascular disease or use of medications for cardiovascular disease - Current or prior history of hypertension or use of blood pressure lowering medications - Current or prior history of diabetes mellitus or use of anti-diabetic medications - Prevalent renal disease (eGFR < 60 ml/min/1.73m2), abnormal serum sodium or potassium - Current or prior smoker - Current pregnancy, or use of hormone replacement therapy or oral contraceptive - Current steroid use - Contraindications to MRI - Active infection or open wounds on the top of the feet or hands

性别

参与研究的性别:

All

年龄

最小年龄：18 Years ，最大年龄：55 Years

接受健康的志愿者

没有

可入组国家 ^ICMJE

United States

管理信息

数据检测委员会

研究涉及美国FDA监管的产品

研究美国FDA监管的药品: No
研究涉及美国FDA监管的设备产品: No

IPD 共享声明

计划分享 IPD:

Yes

责任方

Rachelle Crescenzi，Vanderbilt University Medical Center

研究赞助商 ^ICMJE

Vanderbilt University Medical Center

合作者 ^ICMJE

研究员 ^ICMJE

Principal Investigator: Rachelle Crescenzi, PhD Department of Radiology, Vanderbilt University Medical Center

PRS 账户

Vanderbilt University Medical Center

验证日期

October 2018

^ICMJE 国际医学期刊编辑委员会和世界卫生组织 ICTRP 要求的元素

请使用微信扫码报名