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

Last updated: June 10, 2025
Sponsor: University of Copenhagen
Overall Status: Active - Recruiting

Phase

N/A

Condition

Fast Heart Rate (Tachycardia)

Heart Disease

Heart Defect

Treatment

GLP-1R antagonist

Saline/Placebo

GIPR antagonist

Clinical Study ID

NCT07019519
H-24030176
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

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 Criteria

Inclusion

Inclusion Criteria POTS patients:

  • Previously diagnosed with POTS in tilt test or active stand-test (either newlydiagnosed within last 3 months or in new tilt test/active stand test duringscreenings visit)

  • Reproducible orthostatic intolerance with raise in HR on >30 bpm when standingwithin 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

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 orparticipants 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 orparticipants that receives medicine that cannot be paused for 36 hours

Study Design

Total Participants: 30
Treatment Group(s): 4
Primary Treatment: GLP-1R antagonist
Phase:
Study Start date:
March 15, 2025
Estimated Completion Date:
September 30, 2026

Study Description

Each participant will attend independent randomized experimental days with MR-scans during and intravenous infusions of hormones or placebo and ingestion of glucose or water. A continuous intravenous infusion of either GIP(3-30)NH2, CCK8- or saline for POTS-group or GIP(3-30)NH2, CCK-8, saline or exendin(9-39)NH2 in healthy is started while the participant lie in the scanner while scans, blood samples and questionnaires are repeated over the time course of 2 hours. At a specific timepoint the participants will ingest 75 g of glucose dissolved in 250 ml water.

Connect with a study center

  • Rigshospitalet

    Copenhagen, 2100
    Denmark

    Active - Recruiting

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