BloodpressureGA-25NCT06934473
Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
A study testing GIP(3-30)NH2 / study tool and GIP(1-42) in people with Bloodpressure, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Bloodpressure
- What is being tested?
- GIP(3-30)NH2 / study tool and GIP(1-42)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 2 sitesDenmark
- Study dates
- 21 May 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age 18-40 years
- BMI between 18.5 and 29.9 kg/m2 (both included)
- Informed consent
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark2 sites, 2 recruiting
- Not yet recruiting
Center for Clinical Metabolic Research
Copenhagen, Hellerup, 2900
Lise Wilki-Kurtzhals, MD, +4526204303, lise.wilki-kurtzhals@regionh.dk
Lærke Smidt Gasbjerg, PhD, lsg@sund.ku.dk
- Recruiting
Center for Clinical Metabolic Research
Copenhagen, Hellerup, 2900
Lise Wilki-Kurtzhals, 004526204303, lise.wilki-kurtzhals@regionh.dk
About this study
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.
Read the 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.
- Conditions
- Bloodpressure
- Being tested
- GIP(3-30)NH2 / study tool, Saline (NaCl 0,9 %) (placebo), GIP(1-42)
- Keywords
- Glucose-dependent insulinotropic polypeptide, GIP, GIP receptor antagonist, GIP(3-30)NH2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GIP(3-30)NH2 / study toolOther
Selective antagonist of the GIPR, GIP(3-30)NH2
Saline (NaCl 0,9 %) (placebo)Other
Placebo (NaCl 0,9%)
GIP(1-42)Other
Agonist of the GIPR, GIP(1-42)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: GIP(3-30)NH2 / study tool; Other: 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 Receives: Other: GIP(3-30)NH2 / study tool; Other: 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 Receives: Other: GIP(1-42) |
| Saline + water | Placebo comparator | Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + intake of water Receives: Other: Saline (NaCl 0,9 %) (placebo); Other: GIP(1-42) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From -35 to 50 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start21 May 2025
- Primary completion31 Jan 2026 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BloodpressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lise wilki-kurtzhals, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934473
- Sponsor's protocol ID
- GA-25
- Acronym
- GA-25
- Status last verified
- Sep 2025
- First submitted
- 11 Apr 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
- ClinicalTrials.gov ID
- NCT06934473
- Acronym / sponsor ID
- GA-25 / GA-25
- Conditions
- Bloodpressure
- Keywords
- Glucose-dependent insulinotropic polypeptide, GIP, GIP receptor antagonist, GIP(3-30)NH2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 21 May 2025 (actual)
- Primary completion
- 31 Jan 2026 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 18 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GIP(3-30)NH2 + mixed meal test | Experimental | Other: GIP(3-30)NH2 / study tool, Other: Saline (NaCl 0,9 %) (placebo)Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min + mixed meal test |
| Saline + mixed meal test | Placebo comparator | Other: GIP(3-30)NH2 / study tool, Other: Saline (NaCl 0,9 %) (placebo)Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + mixed meal test |
| GIP(1-42) + water | Active comparator | Other: GIP(1-42)Intravenous infusion of GIP(1-42) in a concentration of 4,000 pmol/kg/min + intake of water |
| Saline + water | Placebo comparator | Other: Saline (NaCl 0,9 %) (placebo), Other: GIP(1-42)Intravenous infusion of saline 9 mg/ml added 0.5% human serum albumin + intake of water |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18-40 years
- BMI between 18.5 and 29.9 kg/m2 (both included)
- Informed consent
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GIP(3-30)NH2 / study toolSelective antagonist of the GIPR, GIP(3-30)NH2 | Other | GIP(3-30)NH2 + mixed meal test, Saline + mixed meal test |
| Saline (NaCl 0,9 %) (placebo)Placebo (NaCl 0,9%) | Other | GIP(3-30)NH2 + mixed meal test, Saline + mixed meal test, Saline + water |
| GIP(1-42)Agonist of the GIPR, GIP(1-42) | Other | GIP(1-42) + water, Saline + water |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Sep 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Center for Clinical Metabolic Research
Copenhagen, Denmark
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GIP(3-30)NH2 / study tool and GIP(1-42) in people with Bloodpressure, run by University Hospital, Gentofte, Copenhagen at 2 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postprandial systolic blood pressure change (delta SBP) (time frame: From -35 to 50 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2025.