Investigating blood flow changes in POTS after glucose intake
Mechanism of Glucose-dependent Insulinotropic Polypeptide (GIP) on Splanchnic Venous Capacitance in Postural Tachycardia Syndrome
This study is testing how eating glucose affects blood flow and symptoms in people with Postural Tachycardia Syndrome (POTS) compared to healthy individuals.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05375968 on ClinicalTrials.gov |
What this trial studies
This study aims to explore how glucose ingestion affects blood flow and symptoms in patients with Postural Tachycardia Syndrome (POTS). It will compare POTS patients experiencing postprandial symptoms with healthy controls, measuring changes in splanchnic venous capacitance and blood flow before and after consuming a glucose solution. The study employs an innovative technique using segmental impedance to assess these changes during different body positions. The goal is to understand the mechanisms behind worsening symptoms in POTS patients after meals.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 to 50 diagnosed with POTS who experience symptoms after meals.
Not a fit: Patients with a BMI over 30, significant heart problems, or those on chronic medications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to better management strategies for POTS patients, particularly regarding dietary recommendations.
How similar studies have performed: While there is preliminary data on the effects of glucose on POTS symptoms, this specific approach to measuring splanchnic venous capacitance is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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. * Subjects 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
Where this trial is running
Nashville, Tennessee
- Vanderbilt University Medical Center — Nashville, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Cyndya Shibao, M.D — Vanderbilt University Medical Center
- Study coordinator: Pedro J Ortiz, MD
- Email: pedro.ortiz.saavedra@vumc.org
- Phone: 689-233-2623
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.