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Trial · Interventional

RecruitingNot applicableRegistry data

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

Short name GA22

NCTNCT07019519 (opens ClinicalTrials.gov in a new tab)Other idH-24030176
Open at ClinicalTrials.govAsk about this trial

This trial does not test a peptide that PepBank tracks.

  • Measures Glucagon, does not give it. It appears in an outcome measure.

Overview

Status
Recruiting
Phase
Not applicable
Enrollment
30 participants (estimated)
Sponsor
University of Copenhagen · Other
Design
Randomized · Single masking
Countries
1 country

Denmark

Start
15 Mar 2025
Primary completion
30 Jun 2026 (estimated)
Completion
30 Sept 2026 (estimated)
First posted
13 Jun 2025
Last update posted
13 Jun 2025
Conditions
Postural Orthostatic Tachycardia Syndrome (POTS) · Healthy

Timeline

1 trial · 1 ongoing

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202520262027
  1. N/A

    GA22

    NCT07019519

    15 Mar 2025 to est. 30 Sept 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • Saline/PlaceboOther
  • GIPR antagonistOther
  • GLP-1R antagonistOther
  • CCK agonistOther

Arms4

  • Active comparator

    Saline

    Saline infusion, oral glucose (POTS and healthy)

  • Experimental

    GIP antagonist

    GIP(3-30)NH2 infusion, oral glucose (POTS and healthy)

  • Experimental

    GLP-1 antagonist

    Exendin(9-39)NH2 infusion, oral glucose (only in healthy)

  • Experimental

    CCK agonist

    CCK-8 infusion, oral glucose (POTS and healthy)

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Continuously for 80 minutes/during infusions

    Registry description

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

Secondary outcomes(9)

  1. Blood flow in portal vein

    Time frame · Continuously for 80 minutes/during infusions

    Registry description

    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

    Registry description

    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

    Registry description

    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)

    Registry description

    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)

    Registry description

    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)

    Registry description

    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

    Registry description

    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)

    Registry description

    Glucose measurements

  9. Blood samples for autoantibodies

    Time frame · One measurement at baseline visit

    Registry description

    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

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

A trial that is still running, or that stopped early, may post results later.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2017

5 results

Acute effects of glucagon-like peptide-1, GLP-19-36 amide, and exenatide on mesenteric blood flow, cardiovascular parameters, and biomarkers in healthy volunteers.

Bremholm et al. 2017Physiological reportscited by 13

PMID 28235974PMC5328764DOI 10.14814/phy2.13102PUB-28235974

CC BY5 results
Download PDFSee results (5)

More studies

1 study on this page

PubMed tag: none · 2023

Predictive Potential of Biomarkers of Intestinal Barrier Function for Therapeutic Management with Teduglutide in Patients with Short Bowel Syndrome.

Büttner et al. 2023Nutrientscited by 4

PMID 37836505PMC10574292DOI 10.3390/nu15194220PUB-37836505

CC BY
Download PDF

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Accepted
Inclusion and exclusion criteria, as posted
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

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