Effect of Dietary Sodium Intake on Vascular Endothelium
- Conditions
- Postural Tachycardia Syndrome (POTS)
- Interventions
- Procedure: Pulsitile Arterial Tonometry (PAT) ProtocolDevice: Calf Blood Flow in Reactive Hyperemia (CBF-RH)Device: Evaluation of Forearm-Mediated Dilation
- Registration Number
- NCT01550315
- Lead Sponsor
- Vanderbilt University Medical Center
- Brief Summary
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.
- Detailed Description
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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 27
- 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
- Overt cause for postural tachycardia (such as acute dehydration)
- Inability to give, or withdrawal of, informed consent
- Pregnant
- Other factors which in the investigator's opinion would prevent the subject from completing the protocol.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Low Sodium Diet (POTS & Controls) Pulsitile Arterial Tonometry (PAT) Protocol 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. High Sodium - POTS & Controls Pulsitile Arterial Tonometry (PAT) Protocol 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. High Sodium - POTS & Controls Calf Blood Flow in Reactive Hyperemia (CBF-RH) 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. High Sodium - POTS & Controls Evaluation of Forearm-Mediated Dilation 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. Low Sodium Diet (POTS & Controls) Calf Blood Flow in Reactive Hyperemia (CBF-RH) 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. Low Sodium Diet (POTS & Controls) Evaluation of Forearm-Mediated Dilation 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.
- Primary Outcome Measures
Name Time Method FMD (% Change) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States