Enrolling by invitation
Not applicable
The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
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
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)
| Facility | City | Region | Status |
| Center for Clinical Metabolic Research |
Copenhagen |
Hellerup |
|
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