Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals

NCT ID: NCT06934473

Last Updated: 2025-09-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-21

Study Completion Date

2026-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bloodpressure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

GIP(3-30)NH2 / study tool

Intervention Type OTHER

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

Saline (NaCl 0,9 %) (placebo)

Intervention Type OTHER

Placebo (NaCl 0,9%)

Saline + mixed meal test

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

Group Type PLACEBO_COMPARATOR

GIP(3-30)NH2 / study tool

Intervention Type OTHER

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

Saline (NaCl 0,9 %) (placebo)

Intervention Type OTHER

Placebo (NaCl 0,9%)

GIP(1-42) + water

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

Group Type ACTIVE_COMPARATOR

GIP(1-42)

Intervention Type OTHER

Agonist of the GIPR, GIP(1-42)

Saline + water

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

Group Type PLACEBO_COMPARATOR

Saline (NaCl 0,9 %) (placebo)

Intervention Type OTHER

Placebo (NaCl 0,9%)

GIP(1-42)

Intervention Type OTHER

Agonist of the GIPR, GIP(1-42)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GIP(3-30)NH2 / study tool

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

Intervention Type OTHER

Saline (NaCl 0,9 %) (placebo)

Placebo (NaCl 0,9%)

Intervention Type OTHER

GIP(1-42)

Agonist of the GIPR, GIP(1-42)

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

lise wilki-kurtzhals

MD, PhD student

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Center for Clinical Metabolic Research

Copenhagen, Hellerup, Denmark

Site Status NOT_YET_RECRUITING

Center for Clinical Metabolic Research

Copenhagen, Hellerup, Denmark

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Denmark

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lise Wilki-Kurtzhals, MD

Role: primary

+4526204303

Lærke Smidt Gasbjerg, PhD

Role: backup

Lise Wilki-Kurtzhals

Role: primary

004526204303

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

GA-25

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.