The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension
- Conditions
- PostPrandial Hypotension
- Interventions
- Other: Intravenous infusion of GIPRAOther: Intravenous infusion of saline
- Registration Number
- NCT06208904
- Lead Sponsor
- University Hospital, Gentofte, Copenhagen
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 18
- Age 18-85 years
- History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
- Informed consent
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist) Intravenous infusion of GIPRA Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min Saline Intravenous infusion of saline Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin
- Primary Outcome Measures
Name Time Method Nadir systolic blood pressure (mmHg) 0-180 minutes Nadir and time to nadir
Nadir systolic blood pressure (SBP) (mmHg) -45-0 minutes Baseline
- Secondary Outcome Measures
Name Time Method Systolic blood pressure (mmHg) 0-180 minutes Peak, nadir and iAUC (incremental area under the curve)
Diastolic blood pressure (mmHg) 0-180 minutes Peak, nadir and iAUC
Stroke volumen (ml) 0-180 minutes Peak, nadir and iAUC
Cardiac output (l/min) 0-180 minutes Peak, nadir and iAUC
Heart rate (beats/min) 0-180 minutes Peak, nadir and iAUC
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
Trial Locations
- Locations (1)
Center for Clinical Metabolic Research
🇩🇰Copenhagen, Hellerup, Denmark