Gut hormone effects on post-meal abdominal blood flow in people with POTS

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Rigshospitalet
  Copenhagen, Denmark Recruiting

Study contacts

• Study coordinator: Sophie W Nielsen, MD
• Email: sophie.nielsen@sund.ku.dk
• Phone: + 45 27 26 79 94

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.