50 Participants Needed

SVC Assessment for POTS

CS
MG
FM
PJ
Overseen ByPedro J Ortiz, MD
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Vanderbilt University Medical Center
Prior Safety DataThis treatment has passed at least one previous human trial

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

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

I am a pre-menopausal woman with a regular menstrual cycle.
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.
See 3 more

Exclusion Criteria

I have rheumatoid arthritis.
I regularly use acetaminophen.
I am taking statins for high cholesterol.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit
1 visit (in-person)

Baseline

Includes Tilt table test, Oral glucose tolerance test (OGTT), Splanchnic venous capacitance measurements

1 visit
1 visit (in-person)

Treatment

Randomization to saline versus GIP antagonist infusion, measurement of splanchnic venous capacitance and superior mesenteric arterial flow

3 hours
2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Measurement of Splanchnic venous capacitance(SVC)
Trial Overview 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.
How Is the Trial Designed?
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
Group II: Effect of GIP antagonist GIP(3-30)NH2 Vs Saline on splanchnic venous capacitance on POTS patientsPlacebo Group2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Vanderbilt University Medical Center

Lead Sponsor

Trials
922
Recruited
939,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

Published Research Related to This Trial

In a study involving chloralose-anesthetized dogs, stimulating the splanchnic nerves at 20 Hz significantly increased vascular resistance by 135% and reduced blood capacitance by 7.20 ml/kg, indicating a strong response in abdominal circulation.
Lower stimulation frequencies (1 and 2 Hz) produced much smaller increases in resistance (14% and 31%) and reduced capacitance responses (3.42 and 5.43 ml/kg), suggesting that higher frequency stimulation is more effective for altering abdominal blood flow dynamics.
Responses of abdominal vascular capacitance to stimulation of splachnic nerves.Karim, F., Hainsworth, R.[2017]
In a study of 17 patients with postural tachycardia syndrome (POTS) and 10 healthy controls, POTS patients exhibited increased splanchnic blood flow and decreased arterial resistance, which contributed to abnormal blood pressure responses during the Valsalva maneuver.
The findings suggest that splanchnic hyperemia and hypervolemia are linked to excessive blood pressure drops in POTS patients, indicating that factors beyond autonomic dysfunction may influence the condition.
Splanchnic hyperemia and hypervolemia during Valsalva maneuver in postural tachycardia syndrome.Stewart, JM., Medow, MS., Montgomery, LD., et al.[2020]
In a study of 20 patients with hepatic cirrhosis and portal hypertension, blood flow in the superior mesenteric artery and splenic artery was significantly higher compared to 20 healthy volunteers, indicating altered blood flow dynamics in these patients.
Increased splanchnic blood flow was primarily observed in patients with splenomegaly, suggesting that the enlargement of the spleen may be a key factor in the changes in blood flow associated with cirrhosis.
Splanchnic blood flow in patients with cirrhosis and portal hypertension: investigation with duplex Doppler US.Zwiebel, WJ., Mountford, RA., Halliwell, MJ., et al.[2016]

Citations

Splanchnic Venous Capacitance in Postural Tachycardia ...Total of 25 participants with diagnosis of POTS will randomized at visit 2, as 1:1 saline vs GIP antagonist GIP(3-30)NH2 At visit 3, the subjects who received ...
Splanchnic Venous Capacitance in Postural Tachycardia ...Participants with POTS will be randomize to either saline versus GIP(3-30)NH2 acute infusion. We will measure changes in their splanchnic venous ...
Worsening Postural Tachycardia Syndrome is Associated ...The dose-dependent efficacy of the glucose-dependent insulinotropic polypeptide receptor antagonist, GIP(3–30)NH2, on GIP actions in humans.
POTS-FLOW: Interplay Between Gut Hormones and ...GIP(3-30)NH2 is an efficacious GIP receptor antagonist in humans: a randomised, double-blinded, placebo-controlled, crossover study. Diabetologia. 2018 Feb ...
Worsening Postural Tachycardia Syndrome Is Associated ...Dose-dependent efficacy of the glucose-dependent insulinotropic polypeptide (GIP) receptor antagonist GIP(3-30)NH2 on GIP actions in humans.
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