What side effects are associated with this type of intervention?

Common treatments for Postural Orthostatic Tachycardia Syndrome (POTS) often include medications like fludrocortisone, midodrine, and beta-blockers. Fludrocortisone can cause side effects such as hypertension, hypokalemia, and fluid retention. Midodrine may lead to scalp tingling, urinary retention, and supine hypertension. Beta-blockers can cause fatigue, bradycardia, and hypotension. Additionally, non-pharmacological approaches like increased fluid and salt intake are used to manage symptoms related to blood pooling in the splanchnic circulation, but these can sometimes lead to gastrointestinal discomfort and bloating.

What prior FDA approvals exist?

There are no specific FDA-approved drugs exclusively for the treatment of Postural Orthostatic Tachycardia Syndrome (POTS). However, treatments often involve off-label use of medications that manage symptoms. These include beta-blockers like propranolol, which reduce heart rate, and fludrocortisone, which increases blood volume. Midodrine, an alpha-agonist, is also used to constrict blood vessels and increase blood pressure. These treatments aim to counteract the excessive blood pooling and vasodilatory effects seen in POTS, similar to the mechanisms being studied in trials involving glucose ingestion and splanchnic blood pooling.

What other types of research exist?

Promising alternatives for POTS patients to avoid the vasodilatory effects of glucose ingestion include: 1) Low-carbohydrate meals to minimize postprandial blood pooling, 2) Medications like midodrine, which is a peripheral alpha-adrenergic agonist that can help manage orthostatic hypotension, and 3) Non-pharmacologic strategies such as physical counter-maneuvers (e.g., leg muscle pumping) to improve venous return and reduce symptoms.

← Back to Search

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

Select...

I am between 18 and 50 years old.

Select...

I am a pre-menopausal woman with a regular menstrual cycle.

Select...

I have been diagnosed with POTS and feel faint after eating.

Select...

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.

Select...

I regularly use acetaminophen.

Select...

My kidney function is not normal.

Select...

I am taking statins for high cholesterol.

Select...

My liver isn't working properly.

Select...

I have a history of heart issues like heart attack or stroke.

Select...

I have had surgery on my neck.

Select...

I have diabetes (type 1 or type 2).

Select...

I have been diagnosed with neuropathy.

Select...

I do not have any current infections.

Select...

I have had seizures in the past.

Select...

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

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.

0 / 16Eligibility criteria met

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.