The Antiemetic Effects of Increased Splanchnic Perfusion, Induced by the Gut Hormone GIP, in Healthy Individuals
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- University of Copenhagen
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Change in GLP-1 induced nausea intensity
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Lærke Smidt Gasbjerg
MD, PhD, Asst. Prof.
University of Copenhagen