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Recruiting Not applicable

POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS

NCT07019519 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2025-03-15
Last updated
2025-06-13

Condition(s) studied

Postural Orthostatic Tachycardia Syndrome (POTS)Healthy

Investigational drug(s) / intervention(s)

Saline/PlaceboGIPR antagonistGLP-1R antagonistCCK agonist

Saline/Placebo: NaCl(9mg/ml)

GIPR antagonist: GIP(3-30)NH2

GLP-1R antagonist: GLP-1(9-39)NH2

CCK agonist: CCK-8

Study summary

This study will describe the interplay between the gut hormones GIP and CCK and their regulation of blood flow to the large vessels in patients with Postural Orthostatic Tachycardia Syndrome (POTS) and GIP, CCK and GLP-1 in healthy. This is addressed by hormone infusions during MR-scans of the abdomen and intake of oral glucose.

Eligibility

Sex
ALL
Min age
18 Years
Max age
50 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR) — Continuously for 80 minutes/during infusions
    Blood flow in the superior mesenteric artery measured with MR ml/min

Trial sites (1)

FacilityCityRegionStatus
Rigshospitalet Copenhagen Denmark Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07019519 on ClinicalTrials.gov ↗ ← All trials in Denmark