SVC Assessment for POTS
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to understand why individuals with postural tachycardia syndrome (POTS) feel worse after consuming high-carbohydrate foods. Researchers seek to determine if increased blood pooling in the stomach area post-meal is linked to these symptoms. Participants will receive glucose (a type of sugar) to observe its effects on blood flow and heart rate while lying down and standing up. The trial seeks individuals diagnosed with POTS who experience dizziness or lightheadedness after meals. The study will measure splanchnic venous capacitance (SVC) to assess changes in blood flow. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant findings.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but it excludes those on chronic medications and certain specific drugs like acetaminophen and statins. It's best to discuss your current medications with the trial coordinators.
What prior data suggests that this measurement of splanchnic venous capacitance is safe?
Research has shown that the treatment GIP(3-30)NH2 works better at certain doses. In earlier studies, participants generally tolerated GIP(3-30)NH2 well, with no major reports of serious side effects. This suggests the treatment is usually safe for people. However, participants should discuss possible risks with their doctors before joining a trial.12345
Why are researchers excited about this trial?
Researchers are excited about this trial because it aims to uncover how the body's blood vessels respond to changes in blood flow and pressure, specifically in people with Postural Tachycardia Syndrome (POTS). Unlike standard treatments that focus on managing symptoms like rapid heart rate, this study is investigating the role of splanchnic venous capacitance (SVC) and glucose-dependent insulinotropic polypeptide (GIP) hormones. The trial could pave the way for new therapies targeting the blood flow dynamics in POTS, offering a fresh perspective on managing this challenging condition. By exploring these unique physiological mechanisms, the trial could lead to breakthroughs in understanding and treating POTS beyond current symptomatic relief options.
What evidence suggests that this trial's treatments could be effective for POTS?
In this trial, one arm will assess the effect of the treatment GIP(3-30)NH2 on people with POTS by blocking a gut hormone that can worsen symptoms. Research has shown that GIP(3-30)NH2 may reduce the effects of this hormone, potentially preventing blood from pooling and improving blood flow after eating. This treatment targets blood volume in the stomach area and may help maintain steady blood pressure and heart rate when standing. Early results suggest that GIP(3-30)NH2 could reduce the dizziness and lightheadedness often experienced in POTS after meals.12345
Who Is on the Research Team?
Cyndya A Shibao, MD
Principal Investigator
Vanderbilt University Medical Center
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline
Includes Tilt table test, Oral glucose tolerance test (OGTT), Splanchnic venous capacitance measurements
Treatment
Randomization to saline versus GIP antagonist infusion, measurement of splanchnic venous capacitance and superior mesenteric arterial flow
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Measurement of Splanchnic venous capacitance(SVC)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Vanderbilt University Medical Center
Lead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator