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The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension (GA-21)

U

University Hospital, Gentofte, Copenhagen

Status

Enrolling

Conditions

PostPrandial Hypotension

Treatments

Other: Intravenous infusion of GIPRA
Other: Intravenous infusion of saline

Study type

Interventional

Funder types

Other

Identifiers

NCT06208904
GIPR-Ant-21

Details and patient eligibility

About

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

Full 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.

Enrollment

18 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  1. Age 18-85 years
  2. History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
  3. Informed consent

Exclusion criteria

  1. Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
  2. Treatment with antihypertensives
  3. Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within 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 trial participation
  6. Any physical or psychological condition that the investigator evaluates would interfere 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 for men)
  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 alanine aminotransferase (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 or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator

Trial design

Primary purpose

Basic Science

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

18 participants in 2 patient groups, including a placebo group

GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist)
Experimental group
Description:
Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min
Treatment:
Other: Intravenous infusion of GIPRA
Saline
Placebo Comparator group
Description:
Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin
Treatment:
Other: Intravenous infusion of saline

Trial contacts and locations

1

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Central trial contact

Lise Wilki-Kurtzhals, MD

Data sourced from clinicaltrials.gov

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