The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension

NCT ID: NCT06208904

Last Updated: 2025-03-14

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-15
• Study Completion Date: 2025-12-31

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.

Conditions

PostPrandial Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

GIPRA (Glucose-dependent Insulinotropic Polypepetide Receptor Antagonist)

Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min

Group Type: EXPERIMENTAL

Intravenous infusion of GIPRA

Intervention Type: OTHER

Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days

Saline

Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin

Group Type: PLACEBO_COMPARATOR

Intravenous infusion of saline

Intervention Type: OTHER

Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days

Interventions

Intravenous infusion of GIPRA

Intravenous infusion of GIP(3-30)NH2 in a concentration of 1,000 pmol/kg/min during experimental days

Intervention Type: OTHER

Intravenous infusion of saline

Intravenous infusion of isotonic saline 9 mg/ml added 0,5% human serum albumin during experimental days

Intervention Type: OTHER

Other Intervention Names

GIP(3-30)NH2; Placebo (Saline)

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Gentofte, Copenhagen

OTHER

Sponsor Role: lead

Responsible Party

lise wilki-kurtzhals

Medical Doctor and PhD student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lise Wilki-Kurtzhals

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Gentofte, Copenhagen

Locations

Center for Clinical Metabolic Research

Copenhagen, Hellerup, Denmark

Countries

Denmark

Other Identifiers

GIPR-Ant-21

Identifier Type: -

Identifier Source: org_study_id