What this trial means for you
This study is recruiting now at 1 US site. It's studying Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2, Compare change is SVC and SMA flow due to saline for postural tachycardia syndrome (pots).
What participants typically get: study medication (or placebo, if the trial uses one) and study-related medical care at no cost, plus close monitoring. Compensation for time and travel varies by study — ask the site. Note that in many trials you can't choose your treatment group, and some participants receive a placebo.
The study, in the sponsor's words
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.
Can you join? The exact criteria
Below is the verbatim eligibility text from the registry — bring it to your doctor; it's written for clinicians, and your own clinician is the right person to interpret it with you.
Full eligibility criteria (for you and your doctor)
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
Study sites by state
Tennessee
- Vanderbilt University Medical Center — Nashville · Recruiting now
View the official record on ClinicalTrials.gov →
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