GastroFlow: Investigation of the Gastrointestinal Blood Flow in Patients With Postprandial Hypotension

N/AEnrolling By InvitationNCT07381816

University of Copenhagen30 enrolled

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

SINGLE

Enrollment

Conditions

Postprandial Hypotension Healthy Blood Flow

Interventions

MRI + GIPR antagonist (Tool)OTHER

GIP(3-30)NH2 infusion, oral glucose during MRI scans

MRI + hangripOTHER

Hangrip exercises, oral glucose during MRI scans

Saline and oral glucoseOTHER

Saline infusion oral glucose during MRI scans

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Glostrup hospital

Glostrup Municipality, Denmark

Outcomes

Primary Outcomes

Blood flow

Redistribution of splanchnic blood flow in the vessel mesenteric superior artery. Measured with functional MRI in ml/min

Time frame: 145 minutes

Secondary Outcomes

Blood flow

Blood flow in vena portae

Time frame: 145 minutes

Blood flow

Blood flow in trunks coeliacus

Time frame: 145 minutes

Data from ClinicalTrials.gov

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