The Antiemetic Effects of Increased Splanchnic Perfusion, Induced by the Gut Hormone GIP, in Healthy Individuals

NCT07687589 — Not applicable, Enrolling by invitation, 14 participants, University of Copenhagen

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07687589, acronym GIP EMESIS
Status	Enrolling by invitation
Phase	Not applicable
Study type	Interventional; randomized, crossover, masking: double, supportive care
Enrollment	14 (Estimated)
Sponsor	University of Copenhagen (Other)
Conditions	Emesis
Interventions	Glucose-dependent Insulinotropic Polypeptide (GIP), GLP-1 (7-36) amide, Apomorphine Injectable Solution, Saline (0.9% NaCl) (Other)
Dates	start 2026-05-19, primary completion 2026-11-30 (estimated), completion 2027-04-28 (estimated), first posted 2026-07-07, last updated 2026-07-07
Locations	1 site in Denmark

-Summary

This study investigates whether the gut hormone glucose-dependent insulinotropic polypeptide (GIP) can reduce feelings of nausea. GIP is naturally released after meals and is administered intravenously to healthy participants during the experiment. Nausea is induced using either glucagon-like peptide 1 (GLP-1), another gut hormone, or apomorphine, a medication known to trigger nausea. By combining these substances, the study aims to determine whether GIP can alleviate nausea. The findings may improve understanding of interactions between the gut and the brain.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions
s.c. injection of GLP-1 and infusion of saline	Active comparator	Other: GLP-1 (7-36) amide; Other: Saline (0.9% NaCl)
s.c. injection of GLP-1 and infusion of GIP	Active comparator	Other: Glucose-dependent Insulinotropic Polypeptide (GIP); Other: GLP-1 (7-36) amide
s.c. injection of apomorphine and infusion of saline	Active comparator	Other: Apomorphine Injectable Solution; Other: Saline (0.9% NaCl)
s.c. injection of apormorphine and infusion of GIP	Active comparator	Other: Glucose-dependent Insulinotropic Polypeptide (GIP); Other: Apomorphine Injectable Solution
s.c. injection of saline and infusion of GIP	Placebo comparator	Other: Glucose-dependent Insulinotropic Polypeptide (GIP); Other: Saline (0.9% NaCl)

Glucose-dependent Insulinotropic Polypeptide (GIP) (Other): GIP - gut hormone
GLP-1 (7-36) amide (Other): gut hormone - GLP-1(7-36)NH2
Apomorphine Injectable Solution (Other): used as a tool to induce nausea
Saline (0.9% NaCl) (Other): Placebo

+Outcome measures

Primary outcomes

Change in GLP-1 induced nausea intensity [From enrollment to the end of treatment at up to 12 weeks.]: The primary endpoint is the change in GLP-1-induced nausea intensity, measured by a 0-100 mm visual analogue scale (VAS), between study visits, with and without GIP infusion.

+Eligibility

Sex: All, ages: 18 Years to 60 Years, accepts healthy volunteers

Inclusion Criteria:

* Men or women, age of 18-60 years
* BMI between 19-27 kg/m2 (both included)
* informed consent

Exclusion Criteria:

* Current or past treatment with GLP-1 or GIP/GLP-1 receptor-targeting compounds within the last six months
* Gastrointestinal disorders that the investigator evaluates could interfere with induction of nausea (e.g. gastroparesis, functional dyspepsia and GI surgery)
* Neurological disorders affecting nausea (e.g. severe migraines and neuropathy)
* Any known eating disorders (e.g. anorexia nervosa and bulimia)
* Pregnancy or breastfeeding
* Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) (> 2 times normal values) or present hepatobiliary disease
* Kidney disease (estimated glomerular filtration rate (eGFR)<90 ml/min/1.73 m2) at screening
* Severe arteriosclerotic heart disease or heart failure (NYHA class II-IV)
* Glycated hemoglobin (HbA1c) ³ 48 mmol/mol and/or diagnosed type 1 or type 2 diabetes
* Any condition that the investigator evaluates would interfere with study participation

+Locations (1)

Facility	City	Country	Status
Center for Clinical Metabolic Research, Herlev-Gentofte Hospital	Hellerup	Denmark