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
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Basic Information
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RECRUITING
NA
30 participants
INTERVENTIONAL
2025-03-15
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
SINGLE
Study Groups
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Saline
Saline infusion, oral glucose (POTS and healthy)
Saline/Placebo
NaCl(9mg/ml)
GIP antagonist
GIP(3-30)NH2 infusion, oral glucose (POTS and healthy)
GIPR antagonist
GIP(3-30)NH2
GLP-1 antagonist
Exendin(9-39)NH2 infusion, oral glucose (only in healthy)
GLP-1R antagonist
GLP-1(9-39)NH2
CCK agonist
CCK-8 infusion, oral glucose (POTS and healthy)
CCK agonist
CCK-8
Interventions
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Saline/Placebo
NaCl(9mg/ml)
GIPR antagonist
GIP(3-30)NH2
GLP-1R antagonist
GLP-1(9-39)NH2
CCK agonist
CCK-8
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
50 Years
ALL
Yes
Sponsors
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Rigshospitalet, Denmark
OTHER
University of Copenhagen
OTHER
Responsible Party
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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
Countries
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Central Contacts
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Facility Contacts
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References
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Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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H-24030176
Identifier Type: -
Identifier Source: org_study_id
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