Postural Orthostatic Tachycardia Syndrome (POTS)GA22NCT07019519
POTS-FLOW: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
A study testing GIPR antagonist, GLP-1R antagonist and CCK agonist in people with Postural Orthostatic Tachycardia Syndrome (POTS) and Healthy, run by University of Copenhagen at 1 site in Denmark.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Postural Orthostatic Tachycardia Syndrome (POTS), Healthy
- What is being tested?
- GIPR antagonist, GLP-1R antagonist and CCK agonist
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Mar 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Rigshospitalet
Copenhagen, 2100
Sophie W Nielsen, MD, 27 26 79 94 ext. +45, sophie.nielsen@sund.ku.dk
About this study
Official title: Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
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.
Read the 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.
- Being tested
- Saline/Placebo, GIPR antagonist, GLP-1R antagonist, CCK agonist
- Keywords
- Postural Orthostatic Tachycardia Syndrome, POTS, Glucose-dependent insulinotropic polypeptide, GIP, Glucagon-like peptide-1, Glucagon-like peptide-2, GLP-1, GLP-2, CCK-8, Cholecystokinin, Splanchnic Blood Flow
- Medical subject headings
- Postural Orthostatic Tachycardia Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Saline/PlaceboOther
NaCl(9mg/ml)
GIPR antagonistOther
GIP(3-30)NH2
GLP-1R antagonistOther
GLP-1(9-39)NH2
CCK agonistOther
CCK-8
| Study group | Role | What they receive |
|---|---|---|
| Saline | Active comparator | Saline infusion, oral glucose (POTS and healthy) Receives: Other: Saline/Placebo |
| GIP antagonist | Experimental | GIP(3-30)NH2 infusion, oral glucose (POTS and healthy) Receives: Other: GIPR antagonist |
| GLP-1 antagonist | Experimental | Exendin(9-39)NH2 infusion, oral glucose (only in healthy) Receives: Other: GLP-1R antagonist |
| CCK agonist | Experimental | CCK-8 infusion, oral glucose (POTS and healthy) Receives: Other: CCK agonist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR)
Blood flow in the superior mesenteric artery measured with MR ml/min
Measured: Continuously for 80 minutes/during infusions
Secondary outcomes (9)
Blood flow in portal vein
Blood flow in the portal vein measured with MR-scans in ml/min
Measured: Continuously for 80 minutes/during infusions
Blood Flow in celiac trunk
Blood flow in the celiac trunk measured with MR-scans in ml/min
Measured: Continuously for 80 minutes/during infusions
Blood Flow in the hepatic artery
Blood flow in the hepatic artery measured with MR-scans in ml/min
Measured: Continuously for 80 minutes/during infusions
Blood samples for hormones
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
Measured: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)
Gastric emptying/Blood sample of paracetamol
Uptake/amount of paracetamol in the blood over time as a measure of gastric emptying
Measured: Every 10-20 minutes before, during and after the infusions and MRI scans (120 minutes)
Symptomscoring
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.
Measured: Continously before and during the infusions (120 minutes)
Blood samples for genes
Genes analyzed from buffycoat:
GLP-1R: NM_002062, GLP-2R: NM_004246, GIPR: NM_000164 and NM_001308418, CCKR: NM_000730 and NM_176875,
Measured: One measurement at baseline visit
Blood sample for glucose
Glucose measurements
Measured: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)
Blood samples for autoantibodies
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
Measured: One measurement at baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start15 Mar 2025
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)Papers the sponsor has linked to this study.
- Other trials for Postural Orthostatic Tachycardia Syndrome (POTS)Studies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Single blinded, randomized, crossover trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Responsible party
- Sponsor
- Investigators
- Lærke S Gasbjerg, MD, PhD, Study chair, University of Copenhagen, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07019519
- Sponsor's protocol ID
- H-24030176
- Acronym
- GA22
- Status last verified
- Jun 2025
- First submitted
- 13 Mar 2025
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Will share upon request
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.
PubMed 18385466Parker 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.
PubMed 7614106Randall 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.
PubMed 31369335Mehr 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.
PubMed 29549458Breier 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.
PubMed 35232225Koffert 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.
PubMed 28258126Asmar 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.
PubMed 28667118Asmar 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.
PubMed 20547981Zadourian 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.
PubMed 29943373Shaw 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.
PubMed 30861229Freeman 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.
PubMed 21431947Thomsen 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.
PubMed 31899791Mar PL, Raj SR. Postural Orthostatic Tachycardia Syndrome: Mechanisms and New Therapies. Annu Rev Med. 2020 Jan 27;71:235-248. doi: 10.1146/annurev-med-041818-011630. Epub 2019 Aug 14.
PubMed 31412221Stewart JM, Medow MS, Glover JL, Montgomery LD. Persistent splanchnic hyperemia during upright tilt in postural tachycardia syndrome. Am J Physiol Heart Circ Physiol. 2006 Feb;290(2):H665-73. doi: 10.1152/ajpheart.00784.2005. Epub 2005 Sep 2.
PubMed 16143646Stewart JM, Montgomery LD. Regional blood volume and peripheral blood flow in postural tachycardia syndrome. Am J Physiol Heart Circ Physiol. 2004 Sep;287(3):H1319-27. doi: 10.1152/ajpheart.00086.2004. Epub 2004 Apr 29.
PubMed 15117717
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
- ClinicalTrials.gov ID
- NCT07019519
- Acronym / sponsor ID
- GA22 / H-24030176
- Keywords
- Postural Orthostatic Tachycardia Syndrome, POTS, Glucose-dependent insulinotropic polypeptide, GIP, Glucagon-like peptide-1, Glucagon-like peptide-2, GLP-1, GLP-2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
- Model description
- Single blinded, randomized, crossover trial
| Arm | Type | Receives |
|---|---|---|
| Saline | Active comparator | Other: Saline/PlaceboSaline infusion, oral glucose (POTS and healthy) |
| GIP antagonist | Experimental | Other: GIPR antagonistGIP(3-30)NH2 infusion, oral glucose (POTS and healthy) |
| GLP-1 antagonist | Experimental | Other: GLP-1R antagonistExendin(9-39)NH2 infusion, oral glucose (only in healthy) |
| CCK agonist | Experimental | Other: CCK agonistCCK-8 infusion, oral glucose (POTS and healthy) |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Saline/PlaceboNaCl(9mg/ml) | Other | Saline |
| GIPR antagonistGIP(3-30)NH2 | Other | GIP antagonist |
| GLP-1R antagonistGLP-1(9-39)NH2 | Other | GLP-1 antagonist |
| CCK agonistCCK-8 | Other | CCK agonist |
Primary outcome
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
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Background: PubMed 18385466Someya 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.
- Background: PubMed 7614106Parker 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.
- Background: PubMed 31369335Randall 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.
- Background: PubMed 29549458Mehr 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.
- Background: PubMed 35232225Breier 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.
- Background: PubMed 28258126Koffert 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.
- Background: PubMed 28667118Asmar 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.
- Background: PubMed 20547981Asmar 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.
- Background: PubMed 29943373Zadourian 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.
- Background: PubMed 30861229Shaw 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.
- Background: PubMed 21431947Freeman 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.
- Background: PubMed 31899791Thomsen 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.
- Individual participant dataSharing planned: Yes. Will share upon request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lærke S Gasbjerg, MD, PhD study chair
University of Copenhagen, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIPR antagonist, GLP-1R antagonist and CCK agonist in people with Postural Orthostatic Tachycardia Syndrome (POTS) and Healthy, run by University of Copenhagen at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie W Nielsen, MD (+ 45 27 26 79 94, sophie.nielsen@sund.ku.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Redistribution of splanchnic blood flow in the vessel mesenteric superior artery (MR) (time frame: Continuously for 80 minutes/during infusions). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07019519, which also lists 56 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.