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Enrolling by invitation NCT07687589

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

No phase Interventional Emesis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Glucose-dependent Insulinotropic Polypeptide (GIP), GLP-1 (7-36) amide, Apomorphine Injectable Solution, Saline (0.9% NaCl).
Who it may be relevant to
Registry conditions: Emesis. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Denmark
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Interventions

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

Primary outcome measures

  • Change in GLP-1 induced nausea intensity [Time frame: From enrollment to the end of treatment at up to 12 weeks.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Crossover
Masking
Double blind
Primary purpose
Supportive care

Study locations

Denmark · 1 center
  • Center for Clinical Metabolic Research, Herlev-Gentofte Hospital — Hellerup

Identifiers

NCT: NCT07687589 · H-25050058

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗