Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: GIP(3-30)NH2 / study tool, Saline (NaCl 0,9 %) (placebo), GIP(1-42).
- Who it may be relevant to
- Registry conditions: Bloodpressure. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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%) - Other GIP(1-42)
Agonist of the GIPR, GIP(1-42)
Primary outcome measures
- Postprandial systolic blood pressure change (delta SBP) [Time frame: From -35 to 50 minutes]
Eligibility criteria
Inclusion criteria
- Age 18-40 years
- BMI between 18.5 and 29.9 kg/m2 (both included)
- Informed consent
Exclusion criteria
- 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Triple blind
- Primary purpose
- Basic science
Study locations
Denmark · 2 centers
- Center for Clinical Metabolic Research — Copenhagen
- Center for Clinical Metabolic Research — Copenhagen
Identifiers
NCT: NCT06934473 · GA-25