GastroFlow: Investigation of the Gastrointestinal Blood Flow in Patients With Postprandial Hypotension
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: MRI + GIPR antagonist (Tool), MRI + hangrip, Saline and oral glucose.
- Who it may be relevant to
- Registry conditions: Postprandial Hypotension, Healthy, Blood Flow. Basic parameters: 18 years — 90 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 →
Overview
This project will describe the mechanisms of action and the relative contributions of GIP to changes in gastrointestinal blood flow induced by oral glucose and endogenous GIP with the use of a receptor antagonists GIP(3-30)NH2 in patients with postprandial hypotension.
Detailed description
Each participant will attend three independent randomised experimental days in the MRI-scanner with intravenous infusion (hormone/placebo) and oral ingestion (glucose): An intravenous infusion of saline or GIP(3-30)NH2 starts at time point -20 minutes.The infusions are combined with an oral glucose tolerance test (75 gram of glucose dissolved in 250 ml water ingested orally) at time point 0 minutes on two of the experimental days (with and without GIP(3-30)NH2). Furthermore one day will be with handgrip exercise, without an infusion. Therefore the first two days are in randomized order.
MRI measurements are repeatedly performed and blood samples are drawn to be analysed for endocrine responses from the intestines and pancreas.
Interventions
- Other MRI + GIPR antagonist (Tool)
GIP(3-30)NH2 infusion, oral glucose during MRI scans - Other MRI + hangrip
Hangrip exercises, oral glucose during MRI scans - Other Saline and oral glucose
Saline infusion oral glucose during MRI scans
Primary outcome measures
- Blood flow [Time frame: 145 minutes]
Secondary outcome measures (2)
- Blood flow [Time frame: 145 minutes]
- Blood flow [Time frame: 145 minutes]
Eligibility criteria
For the PPH group
Inclusion criteria
- Postprandial hypotension
- Symptoms of postprandial hypotension
Exclusion criteria
- Treatment with drugs that cannot be paused for 12 hours
- Metallic implants that does not tolerate MRI
- Any other disease or dysfunction that may disturb blood flow to the gut
- Intake of more than 14 units of alcohol per week or abuse of drugs
- Blood vessels that are not feasible for measuring flow in the MRI scanner
- Low blood percent
- Decreased kidney function
- Decreased liver function
- Claustrophobia
For the healthy group
Inclusion criteria
- Matched by age, gender and BMI
Exclusion criteria
- Postprandial hypotension
- Metallic implants that does not tolerate MRI
- Intake of more than 14 units of alcohol per week or abuse of drugs
- Blood vessels that are not feasible for measuring flow in the MRI scanner
- Low blood percent
- Decreased kidney function
- Decreased liver function
- Claustrophobia
- Autonomic dysfunction or other disease that cause changes in blood pressure during or after a meal
- Intake of pharmaceutical products that influence the blood pressure
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
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Basic science
Study locations
Denmark · 1 center
- Glostrup hospital — Glostrup Municipality
Identifiers
NCT: NCT07381816 · H-25007666 · NNF23OC0082437