Splanchnic Venous Capacitance in Postural Tachycardia Syndrome
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ClinicalTrials.gov Identifier: NCT05375968 |
Recruitment Status :
Recruiting
First Posted : May 17, 2022
Last Update Posted : April 12, 2024
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Postural tachycardia syndrome (POTS) affects ≈3 million young people, characterized by chronic presyncopal symptoms characterized by dizziness, lightheadedness, and orthostatic tachycardia that occur while standing. Across-sectional survey found that 25% of these patients complains that meals rich in carbohydrates are among the factors that further exacerbate POTS's symptoms and cause a myriad of gastrointestinal symptoms.
The splanchnic circulation is the largest blood volume reservoir of the human body, storing ≈25% of the total blood volume and contributing to sudden, and large, fluctuations in the stroke volume (SV). These orthostatic changes in systemic hemodynamics are particularly magnified after meals, due to increased blood volume sequestration triggered by the release of gastrointestinal peptides with vasodilatory properties. The purpose of this study is to determine if the worsening orthostatic tachycardia and symptoms after glucose ingestion in POTS patients are due to a greater increase in splanchnic venous capacitance and excessive blood pooling on standing as compare to Healthy controls
Condition or disease | Intervention/treatment | Phase |
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Postural Tachycardia Syndrome (POTS) | Diagnostic Test: Measurement of Splanchnic venous capacitance(SVC) | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 50 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Mechanism of Glucose-dependent Insulinotropic Polypeptide (GIP) on Splanchnic Venous Capacitance in Postural Tachycardia Syndrome |
Actual Study Start Date : | February 25, 2023 |
Estimated Primary Completion Date : | June 1, 2025 |
Estimated Study Completion Date : | June 1, 2026 |
Arm | Intervention/treatment |
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Splanchnic venous capacitance(SVC).
Splanchnic venous capacitance(SVC), the comparison between participants with POTS (Postural Tachycardia Syndrome) and Healthy Control group.
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Diagnostic Test: Measurement of Splanchnic venous capacitance(SVC)
Effect of glucose on splanchnic venous capacitance in Postural Orthostatic Tachycardia Syndrome
Other Names:
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- Change in splanchnic venous capacitance in Postural Orthostatic Tachycardia Syndrome [ Time Frame: Baseline up to 180 minutes post glucose challenge ]
The changes in splanchnic venous capacitance and superior mesenteric arterial flow will be measured, before and after a 75 gram of oral glucose challenge. It will compared in POTS and Healthy controls.
While segmental bio impedance is monitored, continuous positive airway pressure (CPAP) will be applied sequentially at 0, 4, 8, 12 and 16 cm H2O for about 30 seconds each; this positive airway pressure will increase the intrathoracic pressure, which is transmitted to the venous circulation. Pressure (CPAP pressure, x-axis) - volume (splanchnic vascular volume measured by segmental impedance and expressed as % change from baseline, y-axis) relationships are then constructed to assess for splanchnic venous capacitance.
- Measure Glucose-dependent Insulinotropic polypeptide (GIP) hormone level in POTS patients and Controls after 75 grams of glucose ingestion [ Time Frame: Baseline up to 180 minutes post glucose challenge ]
Measure and compare various GIP hormones (GLP-1, GLP-2, GIP, Vasoactive Intestinal Peptide(VIP)and glucagon) after ingesting 75-gram glucose for up to 180 minutes in POTS patients and healthy controls of similar age and BMI.
Sequential blood draw will done to measure GIP hormones
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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Between 18 and 50years of age
- Cases: Diagnosis of POTS with presyncope symptoms after meals Or
Controls:
- With no significant past medical history, non-smokers and not on chronic medications.
- Body mass index (BMI) between 18.5 to 29.9 kg/m2
- If pre-menopausal women: must have regular menstrual cycle.
Exclusion Criteria:
- BMI above ≥30 kg/m2
- Irregular menstrual cycle
- Intolerance to CPAP.
- Chronic use of acetaminophen
- Heart problems: myocardial infarction, angina, heart failure, stroke
- Undergone any heart related procedures or stents or on pacemaker.
- Uncontrolled hypertension.
- Type 1 or type 2 diabetes mellitus
- Pregnant or breast-feeding women.
- Impaired liver function
- Impaired Kidney function test.
- Anemia (Hematocrit<34%).
- Ongoing substance abuse.
- Subjects with abnormal EKG
- History of seizures.
- Diagnosed with neuropathy due to any reason
- History of neck surgery.
- Smoker,
- On statin therapy for high cholesterol
- Rheumatoid arthritis.
- On oral corticosteroids,
- Current infections
- Documented of moderate decrease in blood volume
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05375968
Contact: Francesca Mckay, BS | 480-457-0800 | francesca.mckay@vumc.org | |
Contact: Meena Golchha, MD | 615-322-3447 | meenakshi.golchha@vumc.org |
United States, Tennessee | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Cyndya Shibao, MD, MSCI cyndya.shibao@vumc.org | |
Contact: Cyndya A Shibao, MD, MSCI 6155120956 cyndya.shibao@vumc.org | |
Principal Investigator: Cyndya Shibao, MD, MSCI |
Principal Investigator: | Cyndya Shibao, M.D | Vanderbilt University Medical Center |
Responsible Party: | Cyndya Shibao, MD, Associate Professor, Vanderbilt University Medical Center |
ClinicalTrials.gov Identifier: | NCT05375968 |
Other Study ID Numbers: |
POTS-GIP R01HL15920301A1 ( Other Grant/Funding Number: NHLBI ) |
First Posted: | May 17, 2022 Key Record Dates |
Last Update Posted: | April 12, 2024 |
Last Verified: | April 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Product Manufactured in and Exported from the U.S.: | No |
Glucose-dependent Insulinotropic Polypeptide (GIP) |
Postural Orthostatic Tachycardia Syndrome Tachycardia Syndrome Disease Pathologic Processes Arrhythmias, Cardiac Heart Diseases |
Cardiovascular Diseases Cardiac Conduction System Disease Orthostatic Intolerance Primary Dysautonomias Autonomic Nervous System Diseases Nervous System Diseases |