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Diagnostic Test
SVC Assessment for POTS
Phase 2
Recruiting
Led By Cyndya Shibao, M.D
Research Sponsored by Vanderbilt University Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Between 18 and 50 years of age
If pre-menopausal women: must have regular menstrual cycle
Must not have
Rheumatoid arthritis
Chronic use of acetaminophen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 0-180 mins
Summary
This trial will study how a sugary drink affects blood vessels in the stomach area of POTS patients. It aims to understand if this causes their symptoms like dizziness and rapid heartbeat. The study will compare these patients to healthy individuals to find out why they react differently.
Who is the study for?
This trial is for adults aged 18-50 with Postural Tachycardia Syndrome (POTS) who experience symptoms like dizziness after meals. Participants should have a BMI of 18.5 to 29.9 and, if female and pre-menopausal, regular menstrual cycles. Exclusions include heart conditions, seizures, neuropathy, pregnancy, substance abuse, certain chronic diseases or medications.
What is being tested?
The study measures the Splanchnic venous capacitance (SVC) in POTS patients compared to healthy controls to see if SVC increases more in POTS patients after eating glucose-rich foods causing worse symptoms.
What are the potential side effects?
Since this trial involves measurement rather than medication or invasive procedures, side effects are minimal but may include discomfort from standing during tests or minor risks associated with non-invasive monitoring.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 50 years old.
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I am a pre-menopausal woman with a regular menstrual cycle.
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I have been diagnosed with POTS and feel faint after eating.
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I am between 18 and 50 years old.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have rheumatoid arthritis.
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I regularly use acetaminophen.
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My kidney function is not normal.
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I am taking statins for high cholesterol.
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My liver isn't working properly.
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I have a history of heart issues like heart attack or stroke.
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I have had surgery on my neck.
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I have diabetes (type 1 or type 2).
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I have been diagnosed with neuropathy.
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I do not have any current infections.
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I have had seizures in the past.
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My blood pressure is not controlled by medication.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 0-180 mins
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~0-180 mins
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Syndrome
Effect of glucose-induced GIP secretion on POTS postprandial symptoms.
Effect of glucose-induced GIP secretion on splanchnic venous capacitance
Secondary study objectives
Measure Glucose-dependent Insulinotropic polypeptide (GIP) hormone level in POTS patients and Controls after 75 grams of glucose ingestion
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Changes in Splanchnic venous capacitance(SVC) before and after a 75-g oral glucose challengeActive Control2 Interventions
To compare and measure changes in 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 hr. between participants with POTS (Postural Tachycardia Syndrome) and Healthy Control group
Various GIP hormones especially GLP-1, GLP-2, glucagon, and other GI hormones before and after a 75-gram oral glucose at different timepoints through out 3 hours of the study visit
Group II: Effect of GIP antagonist GIP(3-30)NH2 Vs Saline on splanchnic venous capacitance on POTS patientsPlacebo Group2 Interventions
POTS patients who participated in Aim 1, will be and randomized to either saline versus GIP antagonist (GIP(3-30)NH2) in Visit 2.
The changes in their splanchnic venous capacitance and superior mesenteric arterial flow will be measured, before and after a 75-g oral glucose challenge during supine and 45-degree head-up tilt positions (orthostatic challenge) for up to 3 hr.
Notably, changes in venous capacitance will be assessed using segmental impedance to measure the effect of graded positive airway pressure (CPAP) on splanchnic blood volume.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) focus on improving blood volume and vascular tone to counteract excessive blood pooling in the splanchnic circulation, which is worsened by carbohydrate-rich meals. Medications like fludrocortisone increase blood volume by promoting sodium retention, while midodrine constricts blood vessels to enhance vascular tone.
Non-pharmacologic strategies, including increased fluid and salt intake, compression garments, and physical maneuvers, also help reduce blood pooling and improve venous return. These treatments are essential for POTS patients as they address the hemodynamic instability causing their symptoms.
Mediation of hyperglycemia-evoked gastric slow-wave dysrhythmias by endogenous prostaglandins.Effects of gastric electrical stimulation with short pulses and long pulses on gastric dysrhythmia and signs induced by vasopressin in dogs.
Mediation of hyperglycemia-evoked gastric slow-wave dysrhythmias by endogenous prostaglandins.Effects of gastric electrical stimulation with short pulses and long pulses on gastric dysrhythmia and signs induced by vasopressin in dogs.
Find a Location
Who is running the clinical trial?
Vanderbilt University Medical CenterLead Sponsor
894 Previous Clinical Trials
934,533 Total Patients Enrolled
16 Trials studying Postural Orthostatic Tachycardia Syndrome
880 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,913 Previous Clinical Trials
47,757,699 Total Patients Enrolled
12 Trials studying Postural Orthostatic Tachycardia Syndrome
910 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Cyndya Shibao, M.DPrincipal InvestigatorVanderbilt University Medical Center
2 Previous Clinical Trials
130 Total Patients Enrolled
2 Trials studying Postural Orthostatic Tachycardia Syndrome
130 Patients Enrolled for Postural Orthostatic Tachycardia Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have rheumatoid arthritis.I regularly use acetaminophen.I am between 18 and 50 years old.I am a pre-menopausal woman with a regular menstrual cycle.I am taking statins for high cholesterol.My liver isn't working properly.I have a history of heart issues like heart attack or stroke.I have had surgery on my neck.Your medical records show a significant decrease in blood volume.I have diabetes (type 1 or type 2).You have an abnormal EKG (electrocardiogram).My kidney function is not normal.I have been diagnosed with neuropathy.I have been diagnosed with POTS and feel faint after eating.I have POTS and feel faint after eating or I'm healthy, don't smoke, and take no regular meds.I do not have any current infections.You cannot tolerate using a CPAP machine.I am a pre-menopausal woman with a regular menstrual cycle.I have had seizures in the past.I am currently taking oral corticosteroids.You smoke cigarettes.Your weight compared to your height is within a certain range.My blood pressure is not controlled by medication.You are currently using drugs or alcohol excessively.You have a body mass index (BMI) higher than 30 kg/m2.Your periods don't come regularly.You have no major health problems, do not smoke, and are not taking long-term medications.Your blood does not have enough red cells (Hematocrit<34%).I am between 18 and 50 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Changes in Splanchnic venous capacitance(SVC) before and after a 75-g oral glucose challenge
- Group 2: Effect of GIP antagonist GIP(3-30)NH2 Vs Saline on splanchnic venous capacitance on POTS patients
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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