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NCT Number: NCT07019519

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

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Rigshospitalet

Copenhagen, 2100, Denmark

Location status: Recruiting

Location contact

Sophie W Nielsen, MD

CONTACT

[email protected]

27 26 79 94 ext. +45

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Saline/Placebo

Other

NaCl(9mg/ml)

GIPR antagonist

Other

GIP(3-30)NH2

GLP-1R antagonist

Other

GLP-1(9-39)NH2

CCK agonist

Other

CCK-8

Primary outcomes

  1. Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)

    Time frame: Continuously for 80 minutes/during infusions

    Blood flow in the superior mesenteric artery measured with MR ml/min

Secondary outcomes

  1. Blood flow in portal vein

    Time frame: Continuously for 80 minutes/during infusions

    Blood flow in the portal vein measured with MR-scans in ml/min

  2. Blood Flow in celiac trunk

    Time frame: Continuously for 80 minutes/during infusions

    Blood flow in the celiac trunk measured with MR-scans in ml/min

  3. Blood Flow in the hepatic artery

    Time frame: Continuously for 80 minutes/during infusions

    Blood flow in the hepatic artery measured with MR-scans in ml/min

  4. Blood samples for hormones

    Time frame: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)

    Blood samples of hormones types:

    GLP-1(7-36 NH2), GLP-2(1-33), GIP(1-42), Exendin(9-39)NH2, GLP-2(3-33), GIP(3-30)NH2, Glucagon, Insulin/C-peptid, CCK

  5. Gastric emptying/Blood sample of paracetamol

    Time frame: Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)

    Uptake/amount of paracetamol in the blood over time as a measure of gastric emptying

  6. Symptomscoring

    Time frame: Continously before and during the infusions (120 minutes)

    Symptomscoring of autonome dysfunction with VOSS (Vanderbilt Orthostatic Symptom Score) questionnaire: this consists of 10 symptoms: lightheadedness, brain fog, shortness of breath, palpitations, tremor, headache, tightness in chest, blurred vision, nausea and sleepiness rated from 0-10 where 0 is not ocurring and 10 is worts experienced.

  7. Blood samples for genes

    Time frame: One measurement at baseline visit

    Genes analyzed from buffycoat:

    GLP-1R: NM_002062, GLP-2R: NM_004246, GIPR: NM_000164 and NM_001308418, CCKR: NM_000730 and NM_176875,

  8. Blood sample for glucose

    Time frame: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)

    Glucose measurements

  9. Blood samples for autoantibodies

    Time frame: One measurement at baseline visit

    Autoantibodies:

    Angiotensin-II-receptor-1 AT1R-ab, Endothelin-receptor-A ETAR-ab, Alpha1 adrenergic-receptor-ab, Alpha2 adrenergic-receptor-ab, Beta1 adrenergic-receptor-ab, Beta2 adrenergic-receptor-ab, Muscarinic cholinergic M1-receptor-ab, Muscarinic cholinergic M2-receptor-ab, Muscarinic cholinergic M3-receptor-ab, Muscarinic cholinergic M4-receptor-ab, Muscarinic cholinergic M5-receptor-ab

Study contacts

Contact information is provided by the study sponsor or research team.

Lærke S Gasbjerg, MD, PhD

CONTACT

[email protected]

+45 25 34 68 94

Sophie W Nielsen, MD

CONTACT

[email protected]

+ 45 27 26 79 94

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

  • Rigshospitalet, Denmark

Registry information

Official study title

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

Acronym: GA22

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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