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

NCT ID: NCT07019519

Last Updated: 2025-06-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-03-15

Study Completion Date

2026-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Postural Orthostatic Tachycardia Syndrome (POTS) Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Single blinded, randomized, crossover trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Saline

Saline infusion, oral glucose (POTS and healthy)

Group Type ACTIVE_COMPARATOR

Saline/Placebo

Intervention Type OTHER

NaCl(9mg/ml)

GIP antagonist

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

Group Type EXPERIMENTAL

GIPR antagonist

Intervention Type OTHER

GIP(3-30)NH2

GLP-1 antagonist

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

Group Type EXPERIMENTAL

GLP-1R antagonist

Intervention Type OTHER

GLP-1(9-39)NH2

CCK agonist

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

Group Type EXPERIMENTAL

CCK agonist

Intervention Type OTHER

CCK-8

Interventions

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Saline/Placebo

NaCl(9mg/ml)

Intervention Type OTHER

GIPR antagonist

GIP(3-30)NH2

Intervention Type OTHER

GLP-1R antagonist

GLP-1(9-39)NH2

Intervention Type OTHER

CCK agonist

CCK-8

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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


* 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
* 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


* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Rigshospitalet, Denmark

OTHER

Sponsor Role collaborator

University of Copenhagen

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lærke S Gasbjerg, MD, PhD

Role: STUDY_CHAIR

University of Copenhagen, Rigshospitalet

Locations

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Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Sophie W Nielsen, MD

Role: CONTACT

+ 45 27 26 79 94

Lærke S Gasbjerg, MD, PhD

Role: CONTACT

+45 25 34 68 94

Facility Contacts

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Sophie W Nielsen, MD

Role: primary

27 26 79 94 ext. +45

References

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Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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H-24030176

Identifier Type: -

Identifier Source: org_study_id

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