Gut hormone effects on post-meal abdominal blood flow in people with POTS
Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
This test will see if giving or blocking certain gut hormones changes abdominal blood flow after a glucose drink in people with POTS and in healthy volunteers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | University of Copenhagen Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT07019519 on ClinicalTrials.gov |
What this trial studies
Participants attend multiple randomized experimental sessions during which they lie in an MRI scanner while receiving intravenous infusions of hormones or saline and, at a set time, drink 75 g of glucose or water. MR scans of the abdomen, blood sampling, and questionnaires are repeated over a two-hour period to measure large-vessel blood flow and hormone responses. The POTS group receives infusions of GIP antagonist or CCK agonist (and saline), while healthy volunteers may also receive a GLP-1R antagonist, allowing comparison of hormone effects between groups. The protocol is crossover and randomized so each participant serves as their own control across sessions.
Who should consider this trial
Good fit: Adults 18–50 with a documented POTS diagnosis (heart rate rise ≥30 bpm on standing within 10 minutes), reproducible orthostatic intolerance, and without major comorbidities or MRI contraindications are ideal candidates.
Not a fit: People with other significant heart disease, uncontrolled blood pressure, reduced kidney or liver function, metallic implants, substance abuse, or other excluded conditions are unlikely to benefit or qualify for participation.
Why it matters
Potential benefit: If successful, the results could reveal hormone-driven mechanisms behind post-meal blood flow changes in POTS and point to new targets for symptom-relief treatments.
How similar studies have performed: Prior work has shown gut hormones can alter blood flow and autonomic responses in healthy people, but applying hormone infusion with MR blood-flow imaging specifically in POTS is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria POTS patients: * Previously diagnosed with POTS in tilt test or active stand-test (either newly diagnosed within last 3 months or in new tilt test/active stand test during screenings visit) * Reproducible orthostatic intolerance with raise in HR on \>30 bpm when standing within 10 minutes of change of supine to standing in age \>19 years or \>40 bpm in age 18-19 years. * POTS symptoms/orthostatic intolerance * Age 18-50 * Waist ratio \<180 cm Exclusion Criteria: * Chronic illness * Metallic implants * Above 10 alcoholic drinks or week or substance abuse * Other types of sinus tachycardia or heart disease * Liverenzymes two times above normal values * Decreased kidney function eGFR \<90 or elevated kreatinkinasis * Thyroid disease or TSH out of reference * Uncontrollable low or high blood pressure * Blood vessels that cannot be visualized on MR * Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours Inclusion Criteria: * Age 18-50 * Waist ratio \<180 cm * Matched a POTS patient in age, sex and BMI Exclusion Criteria: * Chronic illness * Metallic implants * Above 10 alcoholic drinks or week or substance abuse * POTS; other types of sinus tachycardia or heart disease * Liverenzymes two times above normal values * Decreased kidney function eGFR \<90 or elevated kreatinkinasis * Thyroid disease or TSH out of reference * Uncontrollable low or high blood pressure, Orthostatic hypotension * Blood vessels that cannot be visualized on MR * Any disease that might influence the health of the participant during the study or participants that receives medicine that cannot be paused for 36 hours
Where this trial is running
Copenhagen
- Rigshospitalet — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Sophie W Nielsen, MD
- Email: sophie.nielsen@sund.ku.dk
- Phone: + 45 27 26 79 94
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.