PostPrandial Hypotension
Conditions
Keywords
Postprandial hypotension, Glucose-dependent insulinotropic polypeptide, GIP, GIP receptor antagonist, GIP(3-30)NH2
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.
Interventions
OTHERIntravenous 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 isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days
Sponsors
University Hospital, Gentofte, Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Nadir systolic blood pressure (mmHg) | 0-180 minutes | Nadir and time to nadir |
| Nadir systolic blood pressure (SBP) (mmHg) | -45-0 minutes | Baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Systolic blood pressure (mmHg) | -45-0 minutes | Baseline |
| Diastolic blood pressure (mmHg) | -45-0 minutes | Baseline |
| Occurrence of PPH | 0-180 minutes | (Yes/No) PPH is defined as either a drop in SBP \>20 mmHg from baseline or SBP \<90 mmHg |
| Heart rate (beats/min) | -45-0 minutes | Baseline |
| Stroke volumen (ml) | -45-0 minutes | Baseline |
| Cardiac output (l/min) | -45-0 minutes | Baseline |
Other
| Measure | Time frame | Description |
|---|---|---|
| Plasma glucose | -45-0 minutes | Baseline |
| Gastric emptying rate | -45-0 minutes | Plasma acetaminophen, baseline |
| Plasma GIP(3-30)NH2 | -45-0 minutes | Baseline |
Countries
Denmark
Outcome results
None listed