Rigshospitalet
Copenhagen, 2100, Denmark
Location status: Recruiting
NCT Number: NCT07019519
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.
Interested in participating?
Request Info18 year–50 year
All sexes
Interventional
Not applicable
Copenhagen, 2100, Denmark
Location status: Recruiting
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
POTS patients:
Exclusion criteria
Inclusion criteria
Exclusion criteria
NaCl(9mg/ml)
GIP(3-30)NH2
GLP-1(9-39)NH2
CCK-8
Time frame: Continuously for 80 minutes/during infusions
Blood flow in the superior mesenteric artery measured with MR ml/min
Time frame: Continuously for 80 minutes/during infusions
Blood flow in the portal vein measured with MR-scans in ml/min
Time frame: Continuously for 80 minutes/during infusions
Blood flow in the celiac trunk measured with MR-scans in ml/min
Time frame: Continuously for 80 minutes/during infusions
Blood flow in the hepatic artery measured with MR-scans in ml/min
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
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
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.
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,
Time frame: Every 10-20 minutes before and during and after the infusions and MR scans (120 minutes)
Glucose measurements
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
Contact information is provided by the study sponsor or research team.
Lærke S Gasbjerg, MD, PhD
CONTACT
Sophie W Nielsen, MD
CONTACT
University of Copenhagen
Other
Interplay Between Gut Hormones and Autonomic Postprandial Blood Flow Regulation in Patients With POTS
Acronym: GA22
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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