Thinking of joining a study?

Register your interest

Become a volunteer?

NCT06934473 | NOT YET RECRUITING | Bloodpressure

Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
Sponsor:

University Hospital, Gentofte, Copenhagen

Information provided by (Responsible Party):

lise wilki-kurtzhals

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.

Condition or disease

Bloodpressure

Intervention/treatment

GIP(3-30)NH2 + mixed meal test

Saline + mixed meal test

GIP(1-42)

Saline + water

Phase

NA

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 Type : INTERVENTIONAL
Estimated Enrollment : 16 participants
Masking : TRIPLE
Primary Purpose : BASIC_SCIENCE
Official Title : Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals
Actual Study Start Date : 2025-05-01
Estimated Primary Completion Date : 2025-12-31
Estimated Study Completion Date : 2025-12-31

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 40 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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
Effects of Endogenous GIP on Postprandial Blood Pressure in Healthy Individuals

Location Details

NCT06934473

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Not yet recruiting

Denmark, Hellerup

Center for Clinical Metabolic Research

Copenhagen, Hellerup, Denmark, 2900