OTHER
Saline/Placebo
NaCl(9mg/ml)
POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
Status
Recruiting
Phase
Not applicable
Enrollment
30
Locations
1
Results
Not posted
Publications
12
Study summary
What the protocol is testing.
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 detailed 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.
Interventions
Treatment arms and agents.
OTHER
GIPR antagonist
GIP(3-30)NH2
OTHER
GLP-1R antagonist
GLP-1(9-39)NH2
OTHER
CCK agonist
CCK-8
Timeline
From registration to results.
First posted
Jun 13, 2025
Study start
Mar 15, 2025
Primary completion
Jun 30, 2026
Study completion
Sep 30, 2026
Results posted
Not reported
Registry updated
Jun 13, 2025
Outcomes
What the study measures.
Primary outcomes
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)
Time frame · Continuously for 80 minutes/during infusions
Blood flow in the superior mesenteric artery measured with MR ml/min
Secondary outcomes
Blood flow in portal vein
Time frame · Continuously for 80 minutes/during infusions
Blood flow in the portal vein measured with MR-scans in ml/min
Blood Flow in celiac trunk
Time frame · Continuously for 80 minutes/during infusions
Blood flow in the celiac trunk measured with MR-scans in ml/min
Blood Flow in the hepatic artery
Time frame · Continuously for 80 minutes/during infusions
Blood flow in the hepatic artery measured with MR-scans in ml/min
Blood samples for hormones
Time frame · Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)
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
Gastric emptying/Blood sample of paracetamol
Time frame · Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)
Uptake/amount of paracetamol in the blood over time as a measure of gastric emptying
Symptomscoring
Time frame · Continously before and during the infusions (120 minutes)
Symptomscoring of autonome dysfunction with VOSS (Vanderbilt Orthostatic Symptom Score) questionnaire: this consists of 10 symptoms: lightheadedness, brain fog, shortness of breath, palpitations, tremor, headache, tightness in chest, blurred vision, nausea and sleepiness rated from 0-10 where 0 is not ocurring and 10 is worts experienced.
Blood samples for genes
Time frame · One measurement at baseline visit
Genes analyzed from buffycoat: GLP-1R: NM\_002062, GLP-2R: NM\_004246, GIPR: NM\_000164 and NM\_001308418, CCKR: NM\_000730 and NM\_176875,
Blood sample for glucose
Time frame · Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)
Glucose measurements
Blood samples for autoantibodies
Time frame · One measurement at baseline visit
Autoantibodies: Angiotensin-II-receptor-1 AT1R-ab, Endothelin-receptor-A ETAR-ab, Alpha1 adrenergic-receptor-ab, Alpha2 adrenergic-receptor-ab, Beta1 adrenergic-receptor-ab, Beta2 adrenergic-receptor-ab, Muscarinic cholinergic M1-receptor-ab, Muscarinic cholinergic M2-receptor-ab, Muscarinic cholinergic M3-receptor-ab, Muscarinic cholinergic M4-receptor-ab, Muscarinic cholinergic M5-receptor-ab
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 50 Years
- Sex
- ALL
- Healthy volunteers
- Yes
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
Study locations
1 registered sites.
Denmark. Showing up to 24 locations stored in the fast local snapshot.
Rigshospitalet
Copenhagen, Denmark
Publications
Results and literature.
PMID 18385466 ↗Someya N, Endo MY, Fukuba Y, Hayashi N. Blood flow responses in celiac and superior mesenteric arteries in the initial phase of digestion. Am J Physiol Regul Integr Comp Physiol. 2008 Jun;294(6):R1790-6. doi: 10.1152/ajpregu.00553.2007. Epub 2008 Apr 2.PMID 7614106 ↗Parker DR, Carlisle K, Cowan FJ, Corrall RJ, Read AE. Postprandial mesenteric blood flow in humans: relationship to endogenous gastrointestinal hormone secretion and energy content of food. Eur J Gastroenterol Hepatol. 1995 May;7(5):435-40.PMID 31369335 ↗Randall EB, Billeschou A, Brinth LS, Mehlsen J, Olufsen MS. A model-based analysis of autonomic nervous function in response to the Valsalva maneuver. J Appl Physiol (1985). 2019 Nov 1;127(5):1386-1402. doi: 10.1152/japplphysiol.00015.2019. Epub 2019 Aug 1.PMID 29549458 ↗Mehr SE, Barbul A, Shibao CA. Gastrointestinal symptoms in postural tachycardia syndrome: a systematic review. Clin Auton Res. 2018 Aug;28(4):411-421. doi: 10.1007/s10286-018-0519-x. Epub 2018 Mar 16.PMID 35232225 ↗Breier NC, Paranjape SY, Scudder S, Mehr SE, Diedrich A, Flynn CR, Okamoto LE, Hartmann B, Gasbjerg LS, Shibao CA. Worsening Postural Tachycardia Syndrome Is Associated With Increased Glucose-Dependent Insulinotropic Polypeptide Secretion. Hypertension. 2022 May;79(5):e89-e99. doi: 10.1161/HYPERTENSIONAHA.121.17852. Epub 2022 Mar 2.PMID 28258126 ↗Koffert J, Honka H, Teuho J, Kauhanen S, Hurme S, Parkkola R, Oikonen V, Mari A, Lindqvist A, Wierup N, Groop L, Nuutila P. Effects of meal and incretins in the regulation of splanchnic blood flow. Endocr Connect. 2017 Apr;6(3):179-187. doi: 10.1530/EC-17-0015. Epub 2017 Mar 3.PMID 28667118 ↗Asmar M, Asmar A, Simonsen L, Gasbjerg LS, Sparre-Ulrich AH, Rosenkilde MM, Hartmann B, Dela F, Holst JJ, Bulow J. The Gluco- and Liporegulatory and Vasodilatory Effects of Glucose-Dependent Insulinotropic Polypeptide (GIP) Are Abolished by an Antagonist of the Human GIP Receptor. Diabetes. 2017 Sep;66(9):2363-2371. doi: 10.2337/db17-0480. Epub 2017 Jun 30.PMID 20547981 ↗Asmar M, Simonsen L, Madsbad S, Stallknecht B, Holst JJ, Bulow J. Glucose-dependent insulinotropic polypeptide may enhance fatty acid re-esterification in subcutaneous abdominal adipose tissue in lean humans. Diabetes. 2010 Sep;59(9):2160-3. doi: 10.2337/db10-0098. Epub 2010 Jun 14.PMID 29943373 ↗Zadourian A, Doherty TA, Swiatkiewicz I, Taub PR. Postural Orthostatic Tachycardia Syndrome: Prevalence, Pathophysiology, and Management. Drugs. 2018 Jul;78(10):983-994. doi: 10.1007/s40265-018-0931-5.PMID 30861229 ↗Shaw BH, Stiles LE, Bourne K, Green EA, Shibao CA, Okamoto LE, Garland EM, Gamboa A, Diedrich A, Raj V, Sheldon RS, Biaggioni I, Robertson D, Raj SR. The face of postural tachycardia syndrome - insights from a large cross-sectional online community-based survey. J Intern Med. 2019 Oct;286(4):438-448. doi: 10.1111/joim.12895. Epub 2019 Apr 16.PMID 21431947 ↗Freeman R, Wieling W, Axelrod FB, Benditt DG, Benarroch E, Biaggioni I, Cheshire WP, Chelimsky T, Cortelli P, Gibbons CH, Goldstein DS, Hainsworth R, Hilz MJ, Jacob G, Kaufmann H, Jordan J, Lipsitz LA, Levine BD, Low PA, Mathias C, Raj SR, Robertson D, Sandroni P, Schatz I, Schondorff R, Stewart JM, van Dijk JG. Consensus statement on the definition of orthostatic hypotension, neurally mediated syncope and the postural tachycardia syndrome. Clin Auton Res. 2011 Apr;21(2):69-72. doi: 10.1007/s10286-011-0119-5. No abstract available.PMID 31899791 ↗Thomsen RW, Ozturk B, Pedersen L, Nicolaisen SK, Petersen I, Olsen J, Sorensen HT. Hospital Records of Pain, Fatigue, or Circulatory Symptoms in Girls Exposed to Human Papillomavirus Vaccination: Cohort, Self-Controlled Case Series, and Population Time Trend Studies. Am J Epidemiol. 2020 Apr 2;189(4):277-285. doi: 10.1093/aje/kwz284.
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