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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 21, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2025

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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