Status:
ENROLLING_BY_INVITATION
The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
Lead Sponsor:
University Hospital, Gentofte, Copenhagen
Conditions:
PostPrandial Hypotension
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)
Detailed 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 ami...
Eligibility Criteria
Inclusion
- Age 18-85 years
- History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
- Informed consent
Exclusion
- Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
- Treatment with antihypertensives
- Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit
- Allergy or intolerance to ingredients included in the mixed meal
- Any ongoing medication that the investigator evaluates would interfere with trial participation
- Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
- Anaemia (haemoglobin below normal range \<7.3 mmol/L for women and \<8.3 mmol/L for men)
- Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2) at screening
- Known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at screening
- Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial
- Alcohol/drug abuse as per discretion of the investigators
- Pregnancy or breastfeeding
- Participation in any other clinical trial during study period
- Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator
Key Trial Info
Start Date :
May 15 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT06208904
Start Date
May 15 2024
End Date
December 31 2025
Last Update
March 14 2025
Active Locations (1)
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1
Center for Clinical Metabolic Research
Copenhagen, Hellerup, Denmark, 2900