NCT07381816

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
12mo left

Started Sep 2025

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress40%
Sep 2025May 2027

First Submitted

Initial submission to the registry

September 3, 2025

Completed
12 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

February 2, 2026

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2027

Last Updated

February 2, 2026

Status Verified

September 1, 2025

Enrollment Period

1.2 years

First QC Date

September 3, 2025

Last Update Submit

January 27, 2026

Conditions

Keywords

PhysiologyGIPBlood flowPostprandial hypotensionSplanchnic blood flowMesenteric blood flow

Outcome Measures

Primary Outcomes (1)

  • Blood flow

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

    145 minutes

Secondary Outcomes (2)

  • Blood flow

    145 minutes

  • Blood flow

    145 minutes

Study Arms (2)

Postprandial hypotension group

EXPERIMENTAL

MRI scans of PPH patients. 3 interventions

Other: MRI + GIPR antagonist (Tool)Other: MRI + hangripOther: 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 + hangripOther: Saline and oral glucose

Interventions

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

Healthy matched controlsPostprandial hypotension group

Hangrip exercises, oral glucose during MRI scans

Healthy matched controlsPostprandial hypotension group

Saline infusion oral glucose during MRI scans

Healthy matched controlsPostprandial hypotension group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Postprandial hypotension
  • Symptoms of postprandial hypotension

You may not qualify if:

  • 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
  • Matched by age, gender and BMI
  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Glostrup hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Interventions

Magnetic Resonance SpectroscopyEquipment and SuppliesSodium ChlorideGlucose

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative TechniquesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium CompoundsHexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Single blind, placebo controlled, randomized, crossover study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2025

First Posted

February 2, 2026

Study Start

September 15, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

May 1, 2027

Last Updated

February 2, 2026

Record last verified: 2025-09

Locations