GastroFlow: Investigation of the Gastrointestinal Blood F... | NCT07381816

ID	Type	Description	Link
NNF23OC0082437	Other Grant/Funding Number	Novo Nordisk Foundation

Status Module

Record Verification Date

Sep 2025

Overall Recruitment Status or Expanded Access Status

Enrolling by invitation

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 15, 2025Actual

Primary Completion Date

Dec 1, 2026Estimated

Completion Date

May 1, 2027Estimated

First Submitted Date

Sep 3, 2025

First Submission Date that Met QC Criteria

Jan 27, 2026

First Posted Date

Feb 2, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 27, 2026

Last Update Posted Date

Feb 2, 2026Actual

Name	Class
Rigshospitalet, Denmark	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Postprandial hypotension group	Experimental	MRI scans of PPH patients. 3 interventions	Other: MRI + GIPR antagonist (Tool) Other: MRI + hangrip Other: Saline and oral glucose
Healthy matched controls	Placebo Comparator	MRI scans of healthy controls. Crossover design three interventions.	Other: MRI + GIPR antagonist (Tool) Other: MRI + hangrip Other: Saline and oral glucose

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI + GIPR antagonist (Tool)	Other	GIP(3-30)NH2 infusion, oral glucose during MRI scans	Healthy matched controls Postprandial hypotension group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Blood flow	Redistribution of splanchnic blood flow in the vessel mesenteric superior artery. Measured with functional MRI in ml/min	145 minutes

Secondary Outcomes

Measure	Description	Time Frame
Blood flow	Blood flow in vena portae	145 minutes
Blood flow	Blood flow in trunks coeliacus	145 minutes

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Glostrup hospital		Glostrup Municipality		2600	Denmark

Document Section

Large Document Module

Document Has No Statistical Analysis Plan (SAP)

Not provided

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Oct 15, 2025

ID	Term
D009682	Magnetic Resonance Spectroscopy
D004864	Equipment and Supplies
D012965	Sodium Chloride
D005947	Glucose

ID	Term
D013057	Spectrum Analysis
D002623	Chemistry Techniques, Analytical
D008919	Investigative Techniques
D002712	Chlorides
D006851	Hydrochloric Acid
D017606	Chlorine Compounds
D007287	Inorganic Chemicals
D017670	Sodium Compounds
D006601	Hexoses
D009005	Monosaccharides
D000073893	Sugars
D002241	Carbohydrates