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Search / Trial NCT07019519

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

Launched by UNIVERSITY OF COPENHAGEN · Jun 10, 2025

Trial Information

Current as of July 09, 2025

Recruiting

Keywords

Postural Orthostatic Tachycardia Syndrome Pots Glucose Dependent Insulinotropic Polypeptide Gip Glucagon Like Peptide 1 Glucagon Like Peptide 2 Glp 1 Glp 2 Cck 8 Cholecystokinin Splanchnic Blood Flow

ClinConnect Summary

The POTS-FLOW trial is studying how certain gut hormones, specifically GIP and CCK, affect blood flow in people with Postural Orthostatic Tachycardia Syndrome (POTS) after eating. This condition causes an increase in heart rate when standing up, leading to symptoms like dizziness or fainting. The study will also look at how these hormones work in healthy individuals. Participants will receive hormone infusions while undergoing MR scans of their abdomen and will take oral glucose to see how their bodies respond.

To join the study, participants must be between 18 and 50 years old and have a confirmed diagnosis of POTS. They should experience symptoms related to POTS, such as a significant increase in heart rate upon standing. Those with chronic illnesses, certain heart conditions, or who cannot pause specific medications for 36 hours are not eligible. Participants can expect to take part in hormone infusions and MR scans, which are safe and non-invasive procedures. This research aims to improve our understanding of POTS and potentially lead to better treatment options in the future.

Gender

ALL

Eligibility 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

About University Of Copenhagen

The University of Copenhagen, a leading research institution in Denmark, is dedicated to advancing medical knowledge and improving patient outcomes through innovative clinical trials. With a strong emphasis on interdisciplinary collaboration, the university leverages its expertise in various fields, including health sciences, pharmacology, and biotechnology, to design and conduct rigorous clinical studies. Committed to ethical standards and scientific integrity, the University of Copenhagen aims to contribute significantly to the global medical community by facilitating groundbreaking research that addresses pressing healthcare challenges.

Locations

Copenhagen, , Denmark

Patients applied

0 patients applied

Trial Officials

Lærke S Gasbjerg, MD, PhD

Study Chair

University of Copenhagen, Rigshospitalet

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported