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

PostPrandial Hypotension Clinical Trial

— GA-21  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06208904
• Other study ID #: GIPR-Ant-21
• Status: Recruiting
• Phase: N/A
• Start date: March 1, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: February 2024
• Source: University Hospital, Gentofte, Copenhagen
• Contact: Lise Wilki-Kurtzhals, MD
• Phone: +4526204303
• Email: lise.wilki-kurtzhals[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)

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 information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: March 31, 2025
• Est. primary completion date: March 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

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

Related Conditions & MeSH terms

• Hypotension
• PostPrandial Hypotension

Intervention

Other:
• 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

Locations

Country	Name	City	State
Denmark	Center for Clinical Metabolic Research	Copenhagen	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Plasma glucose	Baseline	-45-0 minutes
Other	Plasma glucose	Peak, nadir and iAUC	0-180 minutes
Other	Gastric emptying rate	Plasma acetaminophen, baseline	-45-0 minutes
Other	Gastric emptying rate	Plasma acetaminophen, peak and time to peak	0-180 minutes
Other	Plasma GIP(3-30)NH2	Baseline	-45-0 minutes
Other	Plasma GIP(3-30)NH2	Peak and iAUC	0-180 minutes
Primary	Nadir systolic blood pressure (SBP) (mmHg)	Baseline	-45-0 minutes
Primary	Nadir systolic blood pressure (mmHg)	Nadir and time to nadir	0-180 minutes
Secondary	Occurrence of PPH	(Yes/No) PPH is defined as either a drop in SBP >20 mmHg from baseline or SBP <90 mmHg	0-180 minutes
Secondary	Systolic blood pressure (mmHg)	Baseline	-45-0 minutes
Secondary	Systolic blood pressure (mmHg)	Peak, nadir and iAUC (incremental area under the curve)	0-180 minutes
Secondary	Diastolic blood pressure (mmHg)	Baseline	-45-0 minutes
Secondary	Diastolic blood pressure (mmHg)	Peak, nadir and iAUC	0-180 minutes
Secondary	Heart rate (beats/min)	Baseline	-45-0 minutes
Secondary	Heart rate (beats/min)	Peak, nadir and iAUC	0-180 minutes
Secondary	Stroke volumen (ml)	Baseline	-45-0 minutes
Secondary	Stroke volumen (ml)	Peak, nadir and iAUC	0-180 minutes
Secondary	Cardiac output (l/min)	Baseline	-45-0 minutes
Secondary	Cardiac output (l/min)	Peak, nadir and iAUC	0-180 minutes