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Effect of Dietary Sodium Intake on Vascular Endothelium

Not Applicable
Completed
Conditions
Postural Tachycardia Syndrome (POTS)
Interventions
Procedure: Pulsitile Arterial Tonometry (PAT) Protocol
Device: 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
Inclusion Criteria
  • 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
Exclusion Criteria
  • 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
GroupInterventionDescription
Low Sodium Diet (POTS & Controls)Pulsitile Arterial Tonometry (PAT) ProtocolParticipants 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 & ControlsPulsitile Arterial Tonometry (PAT) ProtocolSubjects 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 & ControlsCalf 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 & ControlsEvaluation of Forearm-Mediated DilationSubjects 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 DilationParticipants 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
NameTimeMethod
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
NameTimeMethod

Trial Locations

Locations (1)

Vanderbilt University Medical Center

🇺🇸

Nashville, Tennessee, United States

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