Bloodpressure
Conditions
Keywords
Glucose-dependent insulinotropic polypeptide, GIP, GIP receptor antagonist, GIP(3-30)NH2
Brief 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.
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
OTHERGIP(3-30)NH2 / study tool
Selective antagonist of the GIPR, GIP(3-30)NH2
OTHERSaline (NaCl 0,9 %) (placebo)
Placebo (NaCl 0,9%)
OTHERGIP(1-42)
Agonist of the GIPR, GIP(1-42)
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postprandial systolic blood pressure change (delta SBP) | 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. |
Countries
Denmark
Outcome results
None listed