Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals (GA-25)

September 1, 2025 updated by: lise wilki-kurtzhals, University Hospital, Gentofte, Copenhagen
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The study is an exploratory, randomised, placebo-controlled, double-blinded crossover study comprising four experimental days. Each experimental day consists of a mixed meal test or drinking water, a double-blinded continuous infusion of GIP(3-30)NH2 or placebo or GIP(1-42) or placebo, and three tilt tests. Sixteen healthy men and women will be included in the study.

Study Type

Interventional

Enrollment (Estimated)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Hellerup
      • Copenhagen, Hellerup, Denmark, 2900
      • Copenhagen, Hellerup, Denmark, 2900
        • Not yet recruiting
        • Center for Clinical Metabolic Research
        • Contact:
        • Sub-Investigator:
          • Casper Nielsen, Postdoc
        • Sub-Investigator:
          • Asger Lund, PhD
        • Sub-Investigator:
          • Mikkel Christensen, Professor
        • Contact:
        • Sub-Investigator:
          • Lærke Gasbjerg, Postdoc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Age 18-40 years
  2. BMI between 18.5 and 29.9 kg/m2 (both included)
  3. Informed consent

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GIP(3-30)NH2 + mixed meal test
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 tool
Selective antagonist of the GIPR, GIP(3-30)NH2
Other: Saline (NaCl 0,9 %) (placebo)
Placebo (NaCl 0,9%)
Placebo Comparator: Saline + mixed meal test
Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + mixed meal test
Other: GIP(3-30)NH2 / study tool
Selective antagonist of the GIPR, GIP(3-30)NH2
Other: Saline (NaCl 0,9 %) (placebo)
Placebo (NaCl 0,9%)
Active Comparator: GIP(1-42) + water
Intravenous infusion of GIP(1-42) in a concentration of 4,000 pmol/kg/min + intake of water
Other: GIP(1-42)
Agonist of the GIPR, GIP(1-42)
Placebo Comparator: Saline + water
Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + intake of water
Other: Saline (NaCl 0,9 %) (placebo)
Placebo (NaCl 0,9%)
Other: GIP(1-42)
Agonist of the GIPR, GIP(1-42)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postprandial systolic blood pressure change (delta SBP)
Time Frame: From -35 to 50 minutes
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Gentofte, Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 21, 2025

Primary Completion (Estimated)

January 31, 2026

Study Completion (Estimated)

January 31, 2026

Study Registration Dates

First Submitted

April 11, 2025

First Submitted That Met QC Criteria

April 11, 2025

First Posted (Actual)

April 18, 2025

Study Record Updates

Last Update Posted (Estimated)

September 8, 2025

Last Update Submitted That Met QC Criteria

September 1, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GA-25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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