RECRUITING

Splanchnic Venous Capacitance in Postural Tachycardia Syndrome

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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. The splanchnic circulation is the largest blood volume reservoir of the human body, storing ≈25% of the total blood volume and contributing to sudden, and large, fluctuations in the stroke volume (SV). The orthostatic changes in systemic hemodynamics are particularly magnified after meals, due to increased blood volume sequestration triggered by the release of gastrointestinal peptides with vasodilatory properties. The purpose of this study is to determine if the worsening orthostatic tachycardia and symptoms after glucose ingestion in POTS patients are due to a greater increase in splanchnic venous capacitance and excessive blood pooling on standing as compare to Healthy controls. The study will also determine if glucose-induced GIP secretion increases splanchnic venous capacitance, orthostatic tachycardia and worsening POTS postprandial symptoms. For this purpose subjects will be further randomized to either saline versus GIP(3-30)NH2 acute infusion, to measure the changes their 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 hours.

Official Title

Mechanism of Glucose-dependent Insulinotropic Polypeptide (GIP) on Splanchnic Venous Capacitance in Postural Tachycardia Syndrome

Quick Facts

Study Start:2023-02-25
Study Completion:2026-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05375968

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 50 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Between 18 and 50years of age
  2. * Cases: Diagnosis of POTS with presyncope symptoms after meals Or
  3. * With no significant past medical history, non-smokers and not on chronic medications.
  4. * Body mass index (BMI) between 18.5 to 29.9 kg/m2
  5. * If pre-menopausal women: must have regular menstrual cycle.
  1. * BMI above ≥30 kg/m2
  2. * Irregular menstrual cycle
  3. * Intolerance to CPAP.
  4. * Chronic use of acetaminophen
  5. * Heart problems: myocardial infarction, angina, heart failure, stroke
  6. * Undergone any heart related procedures or stents or on pacemaker.
  7. * Uncontrolled hypertension.
  8. * Type 1 or type 2 diabetes mellitus
  9. * Pregnant or breast-feeding women.
  10. * Impaired liver function
  11. * Impaired Kidney function test.
  12. * Anemia (Hematocrit\<34%).
  13. * Ongoing substance abuse.
  14. * Subjects with abnormal EKG
  15. * History of seizures.
  16. * Diagnosed with neuropathy due to any reason
  17. * History of neck surgery.
  18. * Smoker,
  19. * On statin therapy for high cholesterol
  20. * Rheumatoid arthritis.
  21. * On oral corticosteroids,
  22. * Current infections
  23. * Documented of moderate decrease in blood volume

Contacts and Locations

Study Contact

Francesca Mckay, BS
CONTACT
480-457-0800
francesca.mckay@vumc.org
Meena Golchha, MD
CONTACT
615-322-3447
meenakshi.golchha@vumc.org

Principal Investigator

Cyndya Shibao, M.D
PRINCIPAL_INVESTIGATOR
Vanderbilt University Medical Center

Study Locations (Sites)

Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States

Collaborators and Investigators

Sponsor: Vanderbilt University Medical Center

  • Cyndya Shibao, M.D, PRINCIPAL_INVESTIGATOR, Vanderbilt University Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-25
Study Completion Date2026-06-01

Study Record Updates

Study Start Date2023-02-25
Study Completion Date2026-06-01

Terms related to this study

Keywords Provided by Researchers

  • Glucose-dependent Insulinotropic Polypeptide (GIP)

Additional Relevant MeSH Terms

  • Postural Tachycardia Syndrome (POTS)