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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 below
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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:
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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 weeks
Treatment ~ Varies
Follow Up ~0-180 mins
This trial's timeline: 3 weeks for screening, Varies for treatment, and 0-180 mins for reporting.

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.

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

Measurement of Splanchnic venous capacitance(SVC) (Diagnostic Test) Clinical Trial Eligibility Overview. Trial Name: NCT05375968 — Phase 2
Postural Orthostatic Tachycardia Syndrome Research Study Groups: Changes in Splanchnic venous capacitance(SVC) before and after a 75-g oral glucose challenge, Effect of GIP antagonist GIP(3-30)NH2 Vs Saline on splanchnic venous capacitance on POTS patients
Postural Orthostatic Tachycardia Syndrome Clinical Trial 2023: Measurement of Splanchnic venous capacitance(SVC) Highlights & Side Effects. Trial Name: NCT05375968 — Phase 2
Measurement of Splanchnic venous capacitance(SVC) (Diagnostic Test) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05375968 — Phase 2
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