POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS (GA22)

University of Copenhagen

Status: Enrolling

Conditions: Healthy; Postural Orthostatic Tachycardia Syndrome (POTS)

Treatments: Other: GIPR antagonist; Other: Saline/Placebo; Other: CCK agonist; Other: GLP-1R antagonist

Study type: Interventional

Funder types: Other

Identifiers

NCT07019519

H-24030176

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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30 participants in 4 patient groups

Saline

Active Comparator group

Description:

Saline infusion, oral glucose (POTS and healthy)

Treatment:

Other: Saline/Placebo

GIP antagonist

Experimental group

Description:

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

Treatment:

Other: GIPR antagonist

GLP-1 antagonist

Experimental group

Description:

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

Treatment:

Other: GLP-1R antagonist

CCK agonist

Experimental group

Description:

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

Treatment:

Other: CCK agonist