The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension

Last updated: March 11, 2025
Sponsor: University Hospital, Gentofte, Copenhagen
Overall Status: Active - Enrolling

Phase

N/A

Condition

Dizzy/fainting Spells

Circulation Disorders

Vascular Diseases

Treatment

Intravenous infusion of GIPRA

Intravenous infusion of saline

Clinical Study ID

NCT06208904
GIPR-Ant-21
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Age 18-85 years

  2. History of PPH-related symptoms like dizziness, lightheadedness, palpitations, orfainting after meal ingestion

  3. Informed consent

Exclusion

Exclusion Criteria:

  1. Not fulfilling the PPH diagnosis during the mixed meal test or during the test mealwith increased (+25%) number of calories

  2. Treatment with antihypertensives

  3. Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatmentwithin three months before screening visit

  4. Allergy or intolerance to ingredients included in the mixed meal

  5. Any ongoing medication that the investigator evaluates would interfere with trialparticipation

  6. Any physical or psychological condition that the investigator evaluates wouldinterfere with trial participation, including any acute or chronic illnesses

  7. Anaemia (haemoglobin below normal range <7.3 mmol/L for women and <8.3 mmol/L formen)

  8. Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) <45 ml/min/1.73 m2) at screening

  9. Known liver disease (except for simple steatosis) and/or elevated plasma alanineaminotransferase (ALT) > three times the upper limit of normal at screening

  10. Any concomitant disease or treatment that, at the discretion of the investigators,might jeopardize the participant's safety during the trial

  11. Alcohol/drug abuse as per discretion of the investigators

  12. Pregnancy or breastfeeding

  13. Participation in any other clinical trial during study period

  14. Mental incapacity or language barriers that preclude adequate understanding orcooperation or unwillingness to comply with trial requirements or pr discretion ofthe investigator

Study Design

Total Participants: 18
Treatment Group(s): 2
Primary Treatment: Intravenous infusion of GIPRA
Phase:
Study Start date:
May 15, 2024
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Center for Clinical Metabolic Research

    Copenhagen, Hellerup 2900
    Denmark

    Site Not Available

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