A Pilot Study of the Effect of Dietary Sodium Intake on Assessments of Vascular Endothelium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 27
- 试验地点
- 1
- 主要终点
- FMD (% Change)
研究概览
简要总结
The investigators will test the hypothesis that markers of vascular endothelial dysfunction will be exaggerated acutely with an extreme high sodium diet compared to an extreme low-sodium diet. The investigators will compare patients with postural orthostatic tachycardia (POTS) to healthy control subjects.
详细描述
The study will involve a crossover design in which each subject will be assessed (as below) while on a very low-sodium (10 mEq/day) diet compared with a very high-sodium diet. These acute dietary interventions will be part of the parent study ("Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387) for 4-5 days at the time of the study. Dietary success will be assessed using a 24h urine for sodium and creatinine as a part of the parent study.
Blood will be drawn and collected in a fasting state for future assay and analysis of the following tests:
- Glucose, Insulin (glucose impairment, insulin resistance)
- Fasting lipid profile
- C-Reactive Protein (hsCRP) (inflammatory state)
- Inflammatory cytokines (inflammatory state)
- aliquots (future analysis)
Pulsitile Arterial Tonometry (PAT) Protocol Calf Blood Flow in Reactive Hyperemia (CBF-RH) - venous occlusion plethysmography Evaluation of Forearm-Mediated Dilation
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387 Postural Tachycardia Syndrome
- •Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- •Subjects will be enrolled in the parent study "Dietary Salt in Postural Tachcyardia Syndrome" funded by R01 HL102387
- •Postural Tachycardia Syndrome
- •Diagnosed with postural tachycardia syndrome by the Vanderbilt Autonomic Dysfunction Center
- •Increase in heart rate ≥30 beats/min with position change from supine to standing (10 minutes)
- •Chronic symptoms consistent with POTS that are worse when upright and get better with recumbence Control Subjects
- •Healthy, non-obese, non-smokers without orthostatic tachycardia
- •Selected to match profiles of POTS patients (gender, age)
- •Not using vasoactive medication
- •Age between 18-60 years
- •Male and female subjects are eligible.
- •Able and willing to provide informed consent
排除标准
- •Overt cause for postural tachycardia (such as acute dehydration)
- •Inability to give, or withdrawal of, informed consent
- •Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
研究组 & 干预措施
High Sodium - POTS & Controls
Subjects will receive a high sodium diet for 4-5 days prior to study day. Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), & evaluation of forearm-mediated dilation.
干预措施: Pulsitile Arterial Tonometry (PAT) Protocol (Procedure)
High Sodium - POTS & Controls
Subjects will receive a high sodium diet for 4-5 days prior to study day. Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), & evaluation of forearm-mediated dilation.
干预措施: Calf Blood Flow in Reactive Hyperemia (CBF-RH) (Device)
High Sodium - POTS & Controls
Subjects will receive a high sodium diet for 4-5 days prior to study day. Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), & evaluation of forearm-mediated dilation.
干预措施: Evaluation of Forearm-Mediated Dilation (Device)
Low Sodium Diet (POTS & Controls)
Participants will consume a very low sodium diet (10 mEq/day) for 4-5 days prior to study day.
Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), & evaluation of forearm-mediated dilation.
干预措施: Pulsitile Arterial Tonometry (PAT) Protocol (Procedure)
Low Sodium Diet (POTS & Controls)
Participants will consume a very low sodium diet (10 mEq/day) for 4-5 days prior to study day.
Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), & evaluation of forearm-mediated dilation.
干预措施: Calf Blood Flow in Reactive Hyperemia (CBF-RH) (Device)
Low Sodium Diet (POTS & Controls)
Participants will consume a very low sodium diet (10 mEq/day) for 4-5 days prior to study day.
Procedures include: blood work, urine collection, Pulsitile Arterial Tonometry (PAT), PAT analysis, Calf Blood Flow in Reactive Hyperemia (CBF-RH), & evaluation of forearm-mediated dilation.
干预措施: Evaluation of Forearm-Mediated Dilation (Device)
结局指标
主要结局
FMD (% Change)
时间窗: FMD was assessed on the morning of day 7, after 6 days of being on either a high salt diet or a low salt diet.
The primary analysis will involve a non-parametric, paired, Signed Rank test of flow mediated dilation (FMD) between all subjects (POTS \& control subjects) on the high sodium diet vs low sodium diet
次要结局
未报告次要终点
研究者
Alfredo Gamboa
Research Associate Professor of Medicine
Vanderbilt University Medical Center