Clinical trial NCT01550315: Effect of Dietary Sodium Intake on Vascular Endothelium
Official title: A Pilot Study of the Effect of Dietary Sodium Intake on Assessments of Vascular Endothelium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Tachycardia Syndrome (POTS)
Keywords: POTS
endothelial function
high salt vs low salt diet
PAT protocol
Calf blood flow
forearm mediated dilation
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2012-03-09
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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

Eligibility criteria: 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.

Primary outcomes:
measure: FMD (% Change)
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University
name: Satish R Raj, MD MSCI
role: PRINCIPAL_INVESTIGATOR
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