Clinical trial NCT06208904: The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
Official title: The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: PostPrandial Hypotension
Keywords: Postprandial hypotension
Glucose-dependent insulinotropic polypeptide
GIP
GIP receptor antagonist
GIP(3-30)NH2
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2024-01-17
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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 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.

Eligibility criteria: 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 outcomes:
measure: Nadir systolic blood pressure (SBP) (mmHg)
timeFrame: -45-0 minutes
measure: Nadir systolic blood pressure (mmHg)
timeFrame: 0-180 minutes
Secondary outcomes:
measure: Occurrence of PPH
timeFrame: 0-180 minutes
measure: Systolic blood pressure (mmHg)
timeFrame: -45-0 minutes
measure: Systolic blood pressure (mmHg)
timeFrame: 0-180 minutes
measure: Diastolic blood pressure (mmHg)
timeFrame: -45-0 minutes
measure: Diastolic blood pressure (mmHg)
timeFrame: 0-180 minutes
measure: Heart rate (beats/min)
timeFrame: -45-0 minutes
measure: Heart rate (beats/min)
timeFrame: 0-180 minutes
measure: Stroke volumen (ml)
timeFrame: -45-0 minutes
measure: Stroke volumen (ml)
timeFrame: 0-180 minutes
measure: Cardiac output (l/min)
timeFrame: -45-0 minutes
measure: Cardiac output (l/min)
timeFrame: 0-180 minutes
Other outcomes:
measure: Plasma glucose
timeFrame: -45-0 minutes
measure: Plasma glucose
timeFrame: 0-180 minutes
measure: Gastric emptying rate
timeFrame: -45-0 minutes
measure: Gastric emptying rate
timeFrame: 0-180 minutes
measure: Plasma GIP(3-30)NH2
timeFrame: -45-0 minutes
measure: Plasma GIP(3-30)NH2
timeFrame: 0-180 minutes
Locations:
city: Copenhagen
country: Denmark
facility: Center for Clinical Metabolic Research
state: Hellerup
Study officials:
affiliation: University Hospital, Gentofte, Copenhagen
name: Lise Wilki-Kurtzhals
role: PRINCIPAL_INVESTIGATOR
References: