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Recruiting Phase 2 NCT05375968

Splanchnic Venous Capacitance in Postural Tachycardia Syndrome

Trial Parameters

Condition Postural Tachycardia Syndrome (POTS)
Sponsor Vanderbilt University Medical Center
Study Type INTERVENTIONAL
Phase Phase 2
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age 50 Years
Start Date 2023-02-25
Completion 2027-05-31
Interventions
Measurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy Controls POTS patientsMeasurement of Splanchnic venous capacitance(SVC)done at Baseline and after 90 min of 75 g glucose in Healthy ControlsCompare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2

Brief Summary

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). The 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. The study will also determine if glucose-induced GIP secretion increases splanchnic venous capacitance, orthostatic tachycardia and worsening POTS postprandial symptoms. For this purpose subjects will be further randomized to either saline versus GIP(3-30)NH2 acute infusion, to measure the changes their splanchnic venous capacitance and superior mesenteric arterial flow before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hours.

Eligibility Criteria

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 ar

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