NCT06934473

Brief Summary

The present study investigates the postprandial role of endogenous glucose-dependent insulinotropic polypeptide (GIP) on cardiovascular haemodynamics, hormone responses, and hypotensive symptoms during a tilt test.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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

First Submitted

Initial submission to the registry

April 11, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

May 21, 2025

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

September 8, 2025

Status Verified

September 1, 2025

Enrollment Period

9 months

First QC Date

April 11, 2025

Last Update Submit

September 1, 2025

Conditions

Bloodpressure

Keywords

Glucose-dependent insulinotropic polypeptideGIPGIP receptor antagonistGIP(3-30)NH2

Outcome Measures

Primary Outcomes (1)

  • Postprandial systolic blood pressure change (delta SBP)

    The mean difference between postprandial systolic blood pressure-change (delta SBP) during tilt test following infusion of GIP(3-30)NH2 compared to infusion of placebo.

    From -35 to 50 minutes

Study Arms (4)

GIP(3-30)NH2 + mixed meal test

EXPERIMENTAL

Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min + mixed meal test

Other: GIP(3-30)NH2 / study toolOther: Saline (NaCl 0,9 %) (placebo)

Saline + mixed meal test

PLACEBO COMPARATOR

Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + mixed meal test

Other: GIP(3-30)NH2 / study toolOther: Saline (NaCl 0,9 %) (placebo)

GIP(1-42) + water

ACTIVE COMPARATOR

Intravenous infusion of GIP(1-42) in a concentration of 4,000 pmol/kg/min + intake of water

Other: GIP(1-42)

Saline + water

PLACEBO COMPARATOR

Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + intake of water

Other: Saline (NaCl 0,9 %) (placebo)Other: GIP(1-42)

Interventions

GIP(3-30)NH2 / study toolOTHER

Selective antagonist of the GIPR, GIP(3-30)NH2

GIP(3-30)NH2 + mixed meal testSaline + mixed meal test
Saline (NaCl 0,9 %) (placebo)OTHER

Placebo (NaCl 0,9%)

GIP(3-30)NH2 + mixed meal testSaline + mixed meal testSaline + water
GIP(1-42)OTHER

Agonist of the GIPR, GIP(1-42)

GIP(1-42) + waterSaline + water

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-40 years
  • BMI between 18.5 and 29.9 kg/m2 (both included)
  • Informed consent

You may not qualify if:

  • Allergy or intolerance to ingredients included in the mixed meal
  • History of Orthostatic Hypotension (OH) or Postural Orthostatic Tachycardia Syndrome (POTS) or other autonomic dysfunction at the discretion of the investigators
  • Anaemia (haemoglobin below normal range \<7.3 mmol/L for women and \<8.3 mmol/L for men)
  • Kidney disease (estimated glomerular filtration rate (eGFR) \<90 ml/min/1.73 m2) at screening
  • Known liver disease and/or elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at screening
  • Treatment with antihypertensives
  • Treatment with GLP-1RA (Glucagon-like Peptide-1 Receptor Agonist)
  • Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within two weeks before the first experimental day
  • Any ongoing medication that the investigator evaluates would interfere with trial participation
  • Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
  • Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial
  • Alcohol/drug abuse as per discretion of the investigators
  • Pregnancy or breastfeeding
  • Participation in any other clinical trial during the study period
  • Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

NOT YET RECRUITING

Center for Clinical Metabolic Research

Copenhagen, Hellerup, 2900, Denmark

RECRUITING

MeSH Terms

Interventions

gastric inhibitory polypeptide (3-30)-amideSodium Chloridegastric inhibitory polypeptide (1-42)

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD student

Study Record Dates

First Submitted

April 11, 2025

First Posted

April 18, 2025

Study Start

May 21, 2025

Primary Completion

January 31, 2026

Study Completion

January 31, 2026

Last Updated

September 8, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

DK(2)