PostPrandial HypotensionGA-21NCT06208904
The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
A study testing Intravenous infusion of GIPRA and Intravenous infusion of saline in people with PostPrandial Hypotension, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH) Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- PostPrandial Hypotension
- What is being tested?
- Intravenous infusion of GIPRA and Intravenous infusion of saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 15 May 2024to 31 Dec 2025
- 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 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-85 years
- History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
- Informed consent
Who cannot join
- Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
- Treatment with antihypertensives
- Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit
- Allergy or intolerance to ingredients included in the mixed meal
- 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
Show all 14Show fewer
- Anaemia (haemoglobin below normal range <7.3 mmol/L for women and <8.3 mmol/L for men)
- Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2) at screening
- Known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal at screening
- 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 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
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site
Center for Clinical Metabolic Research
Copenhagen, Hellerup, 2900
About this study
The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)
Read the detailed description
The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH will be included in the study.
- Conditions
- PostPrandial Hypotension
- Being tested
- Intravenous infusion of GIPRA, Intravenous infusion of saline
- Keywords
- Postprandial hypotension, 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.
Intravenous infusion of GIPRAOther
Also called GIP(3-30)NH2
Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days
Intravenous infusion of salineOther
Also called Placebo (Saline)
Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days
| Study group | Role | What they receive |
|---|---|---|
| GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist) | Experimental | Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min Receives: Other: Intravenous infusion of GIPRA |
| Saline | Placebo comparator | Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin Receives: Other: Intravenous infusion of saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Nadir systolic blood pressure (SBP) (mmHg)
Baseline
Measured: -45-0 minutes
Nadir systolic blood pressure (mmHg)
Nadir and time to nadir
Measured: 0-180 minutes
Secondary outcomes (11)
Occurrence of PPH
(Yes/No) PPH is defined as either a drop in SBP >20 mmHg from baseline or SBP <90 mmHg
Measured: 0-180 minutes
Systolic blood pressure (mmHg)
Baseline
Measured: -45-0 minutes
Systolic blood pressure (mmHg)
Peak, nadir and iAUC (incremental area under the curve)
Measured: 0-180 minutes
Diastolic blood pressure (mmHg)
Baseline
Measured: -45-0 minutes
Diastolic blood pressure (mmHg)
Peak, nadir and iAUC
Measured: 0-180 minutes
Heart rate (beats/min)
Baseline
Measured: -45-0 minutes
Heart rate (beats/min)
Peak, nadir and iAUC
Measured: 0-180 minutes
Stroke volumen (ml)
Baseline
Measured: -45-0 minutes
Stroke volumen (ml)
Peak, nadir and iAUC
Measured: 0-180 minutes
Cardiac output (l/min)
Baseline
Measured: -45-0 minutes
Cardiac output (l/min)
Peak, nadir and iAUC
Measured: 0-180 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2024
- Study start15 May 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PostPrandial HypotensionStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 18 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
- Investigators
- Lise Wilki-Kurtzhals, Principal investigator, University Hospital, Gentofte, Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06208904
- Sponsor's protocol ID
- GIPR-Ant-21
- Acronym
- GA-21
- Status last verified
- Mar 2025
- First submitted
- 5 Jan 2024
- Last updated
- 14 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
- ClinicalTrials.gov ID
- NCT06208904
- Acronym / sponsor ID
- GA-21 / GIPR-Ant-21
- Conditions
- PostPrandial Hypotension
- Keywords
- Postprandial hypotension, Glucose-dependent insulinotropic polypeptide, GIP, GIP receptor antagonist, GIP(3-30)NH2
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Jan 2024 (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 involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)
Detailed description
The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH will be included in the study.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist) | Experimental | Other: Intravenous infusion of GIPRAIntravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min |
| Saline | Placebo comparator | Other: Intravenous infusion of salineIntravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-85 years
- History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
- Informed consent
Key exclusion criteria (14 listed)
- Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
- Treatment with antihypertensives
- Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit
- Allergy or intolerance to ingredients included in the mixed meal
- Any ongoing medication that the investigator evaluates would interfere with trial participation
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 |
|---|---|---|
| Intravenous infusion of GIPRAAlso: GIP(3-30)NH2Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days | Other | GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist) |
| Intravenous infusion of salineAlso: Placebo (Saline)Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days | Other | Saline |
Primary outcome
Nadir systolic blood pressure (SBP) (mmHg)
Time frame: -45-0 minutes
Baseline
Nadir systolic blood pressure (mmHg)
Time frame: 0-180 minutes
Nadir and time to nadir
11 secondary outcomes
Occurrence of PPH
Time frame: 0-180 minutes
Systolic blood pressure (mmHg)
Time frame: -45-0 minutes
Systolic blood pressure (mmHg)
Time frame: 0-180 minutes
Diastolic blood pressure (mmHg)
Time frame: -45-0 minutes
Diastolic blood pressure (mmHg)
Time frame: 0-180 minutes
Heart rate (beats/min)
Time frame: -45-0 minutes
Heart rate (beats/min)
Time frame: 0-180 minutes
Stroke volumen (ml)
Time frame: -45-0 minutes
Stroke volumen (ml)
Time frame: 0-180 minutes
Cardiac output (l/min)
Time frame: -45-0 minutes
Cardiac output (l/min)
Time frame: 0-180 minutes
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 14 Mar 2025.
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Diet and Exercise Solutions to Postprandial Hypotension
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Orthostatic And Postprandial Hypotension In Hospitalized Older Adults (HOPE65)
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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.
Lise Wilki-Kurtzhals principal investigator
University Hospital, Gentofte, Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intravenous infusion of GIPRA and Intravenous infusion of saline in people with PostPrandial Hypotension, run by University Hospital, Gentofte, Copenhagen at 1 site 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 14 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: enrolling by invitation, as of the sponsor's last update on 14 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nadir systolic blood pressure (SBP) (mmHg) (time frame: -45-0 minutes). The study lists 2 primary outcomes in all. 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 14 Mar 2025.