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

NCT07687589 | Enrolling By Invitation DMC

• 1 other identifier: H-25050058
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Emesis

Keywords

GIP; emesis; GLP-1; incretin hormones; nausea

Outcome Measures

Primary Outcomes (1)

• Change in GLP-1 induced nausea intensity

  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.

  From enrollment to the end of treatment at up to 12 weeks.

Study Arms (5)

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)

Interventions

Glucose-dependent Insulinotropic Polypeptide (GIP) OTHER

GIP - gut hormone

s.c. injection of GLP-1 and infusion of GIP; s.c. injection of apormorphine and infusion of GIP; s.c. injection of saline and infusion of GIP

GLP-1 (7-36) amide OTHER

gut hormone - GLP-1(7-36)NH2

s.c. injection of GLP-1 and infusion of GIP; s.c. injection of GLP-1 and infusion of saline

Apomorphine Injectable Solution OTHER

used as a tool to induce nausea

s.c. injection of apomorphine and infusion of saline; s.c. injection of apormorphine and infusion of GIP

Saline (0.9% NaCl) OTHER

Placebo

s.c. injection of GLP-1 and infusion of saline; s.c. injection of apomorphine and infusion of saline; s.c. injection of saline and infusion of GIP

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Copenhagen: lead

Study Sites (1)

Center for Clinical Metabolic Research, Herlev-Gentofte Hospital

Hellerup, 2900, Denmark

Location

MeSH Terms

Conditions

Vomiting; Nausea

Interventions

Incretins; glucagon-like peptide 1 (7-36)amide; Sodium Chloride

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Asst. Prof.

Model Details: Double-blinded, randomized, placebo-controlled, crossover study

Study Record Dates

• First Submitted: June 25, 2026
• First Posted: July 7, 2026
• Study Start: May 19, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): April 28, 2027
• Last Updated: July 7, 2026

Record last verified: 2026-05

Locations

DK (1)