Effect of Dietary Sodium Intake on Vascular Endothelium
NCT ID: NCT01550315
Last Updated: 2022-01-05
Study Results
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View full resultsBasic Information
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COMPLETED
NA
27 participants
INTERVENTIONAL
2012-04-30
2021-09-30
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
BASIC_SCIENCE
NONE
Study Groups
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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.
Pulsitile Arterial Tonometry (PAT) Protocol
* 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.
Calf Blood Flow in Reactive Hyperemia (CBF-RH)
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
Evaluation of Forearm-Mediated Dilation
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.
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.
Pulsitile Arterial Tonometry (PAT) Protocol
* 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.
Calf Blood Flow in Reactive Hyperemia (CBF-RH)
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
Evaluation of Forearm-Mediated Dilation
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.
Interventions
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Pulsitile Arterial Tonometry (PAT) Protocol
* 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.
Calf Blood Flow in Reactive Hyperemia (CBF-RH)
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
Evaluation of Forearm-Mediated Dilation
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
60 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
National Heart, Lung, and Blood Institute (NHLBI)
NIH
Vanderbilt University Medical Center
OTHER
Responsible Party
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Alfredo Gamboa
Research Associate Professor of Medicine
Principal Investigators
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Satish R Raj, MD MSCI
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt University Medical Center
Nashville, Tennessee, United States
Countries
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References
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Centers for Disease Control and Prevention (CDC). Vital signs: prevalence, treatment, and control of hypertension--United States, 1999-2002 and 2005-2008. MMWR Morb Mortal Wkly Rep. 2011 Feb 4;60(4):103-8.
Fujiwara N, Osanai T, Kamada T, Katoh T, Takahashi K, Okumura K. Study on the relationship between plasma nitrite and nitrate level and salt sensitivity in human hypertension : modulation of nitric oxide synthesis by salt intake. Circulation. 2000 Feb 29;101(8):856-61. doi: 10.1161/01.cir.101.8.856.
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Meredith IT, Currie KE, Anderson TJ, Roddy MA, Ganz P, Creager MA. Postischemic vasodilation in human forearm is dependent on endothelium-derived nitric oxide. Am J Physiol. 1996 Apr;270(4 Pt 2):H1435-40. doi: 10.1152/ajpheart.1996.270.4.H1435.
Dakak N, Husain S, Mulcahy D, Andrews NP, Panza JA, Waclawiw M, Schenke W, Quyyumi AA. Contribution of nitric oxide to reactive hyperemia: impact of endothelial dysfunction. Hypertension. 1998 Jul;32(1):9-15. doi: 10.1161/01.hyp.32.1.9.
Higashi Y, Sasaki S, Nakagawa K, Matsuura H, Kajiyama G, Oshima T. A noninvasive measurement of reactive hyperemia that can be used to assess resistance artery endothelial function in humans. Am J Cardiol. 2001 Jan 1;87(1):121-5, A9. doi: 10.1016/s0002-9149(00)01288-1.
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Noon JP, Haynes WG, Webb DJ, Shore AC. Local inhibition of nitric oxide generation in man reduces blood flow in finger pulp but not in hand dorsum skin. J Physiol. 1996 Jan 15;490 ( Pt 2)(Pt 2):501-8. doi: 10.1113/jphysiol.1996.sp021161.
Nohria A, Gerhard-Herman M, Creager MA, Hurley S, Mitra D, Ganz P. Role of nitric oxide in the regulation of digital pulse volume amplitude in humans. J Appl Physiol (1985). 2006 Aug;101(2):545-8. doi: 10.1152/japplphysiol.01285.2005. Epub 2006 Apr 13.
Thijssen DH, Black MA, Pyke KE, Padilla J, Atkinson G, Harris RA, Parker B, Widlansky ME, Tschakovsky ME, Green DJ. Assessment of flow-mediated dilation in humans: a methodological and physiological guideline. Am J Physiol Heart Circ Physiol. 2011 Jan;300(1):H2-12. doi: 10.1152/ajpheart.00471.2010. Epub 2010 Oct 15.
Smith EC, Celedonio J, Nwazue VC, Garland EM, Paranjape SY, Chopoorian AH, Wahba A, Biaggioni I, Black B, Shibao CA, Diedrich A, Okamoto LE, Raj SR, Gamboa A. High-sodium diet does not worsen endothelial function in female patients with postural tachycardia syndrome. Clin Auton Res. 2021 Aug;31(4):563-571. doi: 10.1007/s10286-021-00772-y. Epub 2021 Mar 10.
Clarkson P, Celermajer DS, Powe AJ, Donald AE, Henry RM, Deanfield JE. Endothelium-dependent dilatation is impaired in young healthy subjects with a family history of premature coronary disease. Circulation. 1997 Nov 18;96(10):3378-83. doi: 10.1161/01.cir.96.10.3378.
Al Suwaidi J, Higano ST, Holmes DR Jr, Lennon R, Lerman A. Obesity is independently associated with coronary endothelial dysfunction in patients with normal or mildly diseased coronary arteries. J Am Coll Cardiol. 2001 May;37(6):1523-8. doi: 10.1016/s0735-1097(01)01212-8.
Boger RH, Bode-Boger SM, Szuba A, Tsao PS, Chan JR, Tangphao O, Blaschke TF, Cooke JP. Asymmetric dimethylarginine (ADMA): a novel risk factor for endothelial dysfunction: its role in hypercholesterolemia. Circulation. 1998 Nov 3;98(18):1842-7. doi: 10.1161/01.cir.98.18.1842.
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Quyyumi AA, Dakak N, Andrews NP, Husain S, Arora S, Gilligan DM, Panza JA, Cannon RO 3rd. Nitric oxide activity in the human coronary circulation. Impact of risk factors for coronary atherosclerosis. J Clin Invest. 1995 Apr;95(4):1747-55. doi: 10.1172/JCI117852.
Appel LJ, Frohlich ED, Hall JE, Pearson TA, Sacco RL, Seals DR, Sacks FM, Smith SC Jr, Vafiadis DK, Van Horn LV. The importance of population-wide sodium reduction as a means to prevent cardiovascular disease and stroke: a call to action from the American Heart Association. Circulation. 2011 Mar 15;123(10):1138-43. doi: 10.1161/CIR.0b013e31820d0793. Epub 2011 Jan 13. No abstract available.
Meneton P, Jeunemaitre X, de Wardener HE, MacGregor GA. Links between dietary salt intake, renal salt handling, blood pressure, and cardiovascular diseases. Physiol Rev. 2005 Apr;85(2):679-715. doi: 10.1152/physrev.00056.2003.
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Dishy V, Sofowora GG, Imamura H, Nishimi Y, Xie HG, Wood AJ, Stein CM. Nitric oxide production decreases after salt loading but is not related to blood pressure changes or nitric oxide-mediated vascular responses. J Hypertens. 2003 Jan;21(1):153-7. doi: 10.1097/00004872-200301000-00025.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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111577
Identifier Type: -
Identifier Source: org_study_id
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