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Enrolling by invitation Not applicable

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

NCT06208904 · tracked via the Priya Life Science Denmark tracker
Phase
Not applicable
Started
2024-05-15
Last updated
2025-03-14

Condition(s) studied

PostPrandial Hypotension

Investigational drug(s) / intervention(s)

Intravenous infusion of GIPRAIntravenous infusion of saline

Intravenous infusion of GIPRA: Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days

Intravenous infusion of saline: Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days

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

Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
Accepted
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

Primary outcome measure(s)

  • Nadir systolic blood pressure (SBP) (mmHg) — -45-0 minutes
    Baseline
  • Nadir systolic blood pressure (mmHg) — 0-180 minutes
    Nadir and time to nadir

Trial sites (1)

FacilityCityRegionStatus
Center for Clinical Metabolic Research Copenhagen Hellerup
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06208904 on ClinicalTrials.gov ↗ ← All trials in Denmark