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

NCT07019519 | Recruiting

• 1 other identifier: H-24030176
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Postural Orthostatic Tachycardia Syndrome (POTS); Healthy

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

Outcome Measures

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

  Continuously for 80 minutes/during infusions

Secondary Outcomes (9)

• Blood flow in portal vein

  Continuously for 80 minutes/during infusions

• Blood Flow in celiac trunk

  Continuously for 80 minutes/during infusions

• Blood Flow in the hepatic artery

  Continuously for 80 minutes/during infusions

• Blood samples for hormones

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

• Gastric emptying/Blood sample of paracetamol

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

Study Arms (4)

Saline

ACTIVE COMPARATOR

Saline infusion, oral glucose (POTS and healthy)

Other: Saline/Placebo

GIP antagonist

EXPERIMENTAL

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

Other: GIPR antagonist

GLP-1 antagonist

EXPERIMENTAL

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

Other: GLP-1R antagonist

CCK agonist

EXPERIMENTAL

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

Other: CCK agonist

Interventions

Saline/Placebo OTHER

NaCl(9mg/ml)

Saline

GIPR antagonist OTHER

GIP(3-30)NH2

GIP antagonist

GLP-1R antagonist OTHER

GLP-1(9-39)NH2

GLP-1 antagonist

CCK agonist OTHER

CCK-8

CCK agonist

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• Age 18-50
• Waist ratio \<180 cm
• Matched a POTS patient in age, sex and BMI
• Chronic illness
• Metallic implants

Sponsors & Collaborators

• University of Copenhagen: lead
• Rigshospitalet, Denmark: collaborator

Study Sites (1)

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

Related Publications (56)

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MeSH Terms

Conditions

Postural Orthostatic Tachycardia Syndrome

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Lærke S Gasbjerg, MD, PhD

  University of Copenhagen, Rigshospitalet

  STUDY CHAIR

Central Study Contacts

Sophie W Nielsen, MD

CONTACT

+ 45 27 26 79 94; sophie.nielsen@sund.ku.dk

Lærke S Gasbjerg, MD, PhD

CONTACT

+45 25 34 68 94; lsg@sund.ku.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single blinded, randomized, crossover trial

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: June 13, 2025
• Study Start: March 15, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP
• Time Frame: Data will be shared upon request after study completion
• Access Criteria: Qualified researchers can request access by submitting a proposal to the study sponsor. Data will be shared via a secure online repository upon approval of the request.

Locations

DK (1)