Recruiting PHASE2 Postural Tachycardia Syndrome (POTS)

New treatment option for Postural Tachycardia Syndrome (POTS)

Official title Splanchnic Venous Capacitance in Postural Tachycardia Syndrome

ClinicalTrials.gov ID: NCT05375968

What this study is testing

What is Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2?

Compare change is SVC and SMA flow due to GIP antagonist GIP(3-30)NH2 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for postural tachycardia syndrome (pots).

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Postural tachycardia syndrome (POTS) affects ≈3 million young people, characterized by chronic presyncopal symptoms characterized by dizziness, lightheadedness, and orthostatic tachycardia that occur while standing. Across-sectional survey found that 25% of these patients complains that meals rich in carbohydrates are among the factors that further exacerbate POTS's symptoms and cause a myriad of gastrointestinal symptoms.
  • Phase 2: a mid-size study of how well it works
  • Which group you join is decided by chance.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 50. Healthy volunteers may be eligible.

You may be able to join if

  • Between 18 and 50years of age
  • Cases: Diagnosis of POTS with presyncope symptoms after meals Or Controls:
  • With no significant past medical history, non-smokers and not on chronic medications.
  • Body mass index (BMI) between 18.5 to 29.9 kg/m2
  • If pre-menopausal women: must have regular menstrual cycle.

You likely can't join if

  • BMI above ≥30 kg/m2
  • Irregular menstrual cycle
  • Intolerance to CPAP.
  • Chronic use of acetaminophen
  • Heart problems: myocardial infarction, angina, heart failure, stroke
  • Undergone any heart related procedures or stents or on pacemaker.
See the full eligibility criteria
Who can join
  • Between 18 and 50years of age
  • Cases: Diagnosis of POTS with presyncope symptoms after meals Or Controls:
  • With no significant past medical history, non-smokers and not on chronic medications.
  • Body mass index (BMI) between 18.5 to 29.9 kg/m2
  • If pre-menopausal women: must have regular menstrual cycle.
What rules you out
  • BMI above ≥30 kg/m2
  • Irregular menstrual cycle
  • Intolerance to CPAP.
  • Chronic use of acetaminophen
  • Heart problems: myocardial infarction, angina, heart failure, stroke
  • Undergone any heart related procedures or stents or on pacemaker.
  • Uncontrolled hypertension.
  • Type 1 or type 2 diabetes mellitus
  • Pregnant or breast-feeding women.
  • Impaired liver function
  • Impaired Kidney function test.
  • Anemia (Hematocrit\<34%).
  • Ongoing substance abuse.
  • people with abnormal EKG
  • History of seizures.
  • Diagnosed with neuropathy due to any reason
  • History of neck surgery.
  • Smoker,
  • On statin therapy for high cholesterol
  • Rheumatoid arthritis.
  • On oral corticosteroids,
  • Current infections
  • Documented of moderate decrease in blood volume

The study team makes the final eligibility decision.

Where it's taking place

  • Nashville, Tennessee, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years to 50 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nashville, Tennessee, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.