Menu
Recruiting NCT07019519

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

No phase Interventional Postural Orthostatic Tachycardia Syndrome (POTS) Healthy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Saline/Placebo, GIPR antagonist, GLP-1R antagonist, CCK agonist.
Who it may be relevant to
Registry conditions: Postural Orthostatic Tachycardia Syndrome (POTS), Healthy. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

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

  • Other Saline/Placebo
    NaCl(9mg/ml)
  • Other GIPR antagonist
    GIP(3-30)NH2
  • Other GLP-1R antagonist
    GLP-1(9-39)NH2
  • Other CCK agonist
    CCK-8

Primary outcome measures

  • Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR) [Time frame: Continuously for 80 minutes/during infusions]
Secondary outcome measures (9)
  • Blood flow in portal vein [Time frame: Continuously for 80 minutes/during infusions]
  • Blood Flow in celiac trunk [Time frame: Continuously for 80 minutes/during infusions]
  • Blood Flow in the hepatic artery [Time frame: Continuously for 80 minutes/during infusions]
  • Blood samples for hormones [Time frame: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)]
  • Gastric emptying/Blood sample of paracetamol [Time frame: Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)]
  • Symptomscoring [Time frame: Continously before and during the infusions (120 minutes)]
  • Blood samples for genes [Time frame: One measurement at baseline visit]
  • Blood sample for glucose [Time frame: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)]
  • Blood samples for autoantibodies [Time frame: One measurement at baseline visit]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Basic science

Study locations

Denmark · 1 center
  • Rigshospitalet — Copenhagen

Publications

  • 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 18385466
  • 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 7614106
  • 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 31369335
  • 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 29549458
  • 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 35232225
  • 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 28258126
  • 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 28667118
  • 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 20547981

Identifiers

NCT: NCT07019519 · H-24030176

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗