Effect of Dietary Sodium Intake on Vascular Endothelium

NCT01550315 | Completed Results

• 2 other identifiers: 111577R01HL102387
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Tachycardia Syndrome (POTS)

Keywords

POTS; endothelial function; high salt vs low salt diet; PAT protocol; Calf blood flow; forearm mediated dilation

Outcome Measures

Primary Outcomes (1)

• FMD (% Change)

  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

  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.

Study Arms (2)

High Sodium - POTS & Controls

ACTIVE COMPARATOR

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.

Procedure: Pulsitile Arterial Tonometry (PAT) Protocol; Device: Calf Blood Flow in Reactive Hyperemia (CBF-RH); Device: Evaluation of Forearm-Mediated Dilation

Low Sodium Diet (POTS & Controls)

OTHER

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.

Procedure: Pulsitile Arterial Tonometry (PAT) Protocol; Device: Calf Blood Flow in Reactive Hyperemia (CBF-RH); Device: Evaluation of Forearm-Mediated Dilation

Interventions

Pulsitile Arterial Tonometry (PAT) Protocol PROCEDURE

* A blood pressure cuff will be placed on one upper arm (study arm; non-dominant), while the contralateral arm will serve as a control (control arm). * RH-PAT probes will be placed on one finger (finger II, III, or IV) of each hand (same finger on both hands). The fingers on either side of the one with the probe will be separated using soft sponge rings. * Continuous recording of pulsatile blood volume responses from both hands will be initiated. * After a 10-min equilibration period, the blood pressure cuff on the study arm will be inflated to 60 mm Hg above systolic pressure for 5 min. The cuff will then be deflated to induce reactive hyperemia, PAT recording will be stopped.

Also known as: EndoPat

High Sodium - POTS & Controls; Low Sodium Diet (POTS & Controls)

Calf Blood Flow in Reactive Hyperemia (CBF-RH) DEVICE

Calf blood flow (CBF) will be determined using venous occlusion plethysmography and calibrated mercury strain-gauges during reactive hyperemia after a 5 min of ischemia of the distal limb. Strain-gauges will be applied to the widest part of the non-dominant calf (\~10 cm below patella). Participants will remain quietly supine for 10 min with legs elevated on foam pads above the right atrium to achieve stable baseline measurements of CBF. The venous occlusion cuff is inflated for 4 seconds at 8 seconds intervals, while monitoring the change in resistance in the system, pressure inside the measuring cuff, and 5-10 determinations are performed

Also known as: Hokansan strain guage venous plethysmography

High Sodium - POTS & Controls; Low Sodium Diet (POTS & Controls)

Evaluation of Forearm-Mediated Dilation DEVICE

The arm will be kept extended and immobilized at heart level. Brachial artery diameter will be measured using a high resolution ultrasonography using a linear array probe with a 5 to 17 MHz frequency range. The brachial artery will be imaged in longitudinal sections, 5-10 cm proximal to placement of an occlusion cuff in the dominant forearm just below the antecubital fossa. The probe will be held with a stereotaxic holder with micrometer movement capabilities.

Also known as: Ultrasound

High Sodium - POTS & Controls; Low Sodium Diet (POTS & Controls)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (26)

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  PMID: 33689063 DERIVED

MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Clinical Protocols; Ultrasonography

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Epidemiologic Study Characteristics; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Alfredo Gamboa
• Organization: Vanderbilt Universtiy

alfredo.gamboa@vumc.org

6158751003

Study Officials

• Satish R Raj, MD MSCI

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Associate Professor of Medicine

Study Record Dates

• First Submitted: March 2, 2012
• First Posted: March 9, 2012
• Study Start: April 1, 2012
• Primary Completion: December 1, 2020
• Study Completion: September 1, 2021
• Last Updated: January 5, 2022
• Results First Posted: January 5, 2022

Record last verified: 2021-12

Locations

US (1)