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

N/AEnrolling By InvitationNCT07687589

University of Copenhagen14 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Emesis

Interventions

Glucose-dependent Insulinotropic Polypeptide (GIP)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

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