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

ConditionsPostural Orthostatic Tachycardia Syndrome (POTS)Healthy
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-50
SponsorUniversity of Copenhagen

About this trial

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

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Chronic illness

Metallic implants

Above 10 alcoholic drinks or week or substance abuse

Other types of sinus tachycardia or heart disease

Trial design

Design model

Crossover

Treatments tested in this trial

  • Saline/Placebo

    Other intervention

    NaCl(9mg/ml)

  • GIPR antagonist

    Other intervention

    GIP(3-30)NH2

  • GLP-1R antagonist

    Other intervention

    GLP-1(9-39)NH2

  • CCK agonist

    Other intervention

    CCK-8

Treatment groups

30 Participants
are divided into 4 treatment groups
Group A: SalineActive comparator 1 intervention
Group B: GIP antagonistExperimental treatment 1 intervention
Group C: GLP-1 antagonistExperimental treatment 1 intervention
Group D: CCK agonistExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

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

Time frame
Continuously for 80 minutes/during infusions

Secondary outcomes

1

Blood flow in portal vein

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

Time frame
Continuously for 80 minutes/during infusions
2

Blood Flow in celiac trunk

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

Time frame
Continuously for 80 minutes/during infusions
3

Blood Flow in the hepatic artery

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

Time frame
Continuously for 80 minutes/during infusions
4

Blood samples for hormones

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

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Copenhagen

Lead sponsor

Rigshospitalet, Denmark

Collaborator

Source ClinicalTrials.gov
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