Healthy Young Adults, Physiology
Conditions
Keywords
prostaglandins, glucose, gut hormones, Paracetamol, GLP-1, GIP, meal test
Brief summary
The study aim is to determine whether acute inhibition of endogenous prostaglandin synthesis by paracetamol affects the release of gut hormones, glucose absorption and glycemia in healthy young individuals
Interventions
OTHERParacetamol
Paracetamol is used as a tool to block prostaglandin synthesis
OTHERPlacebo
A placebo will be administered to be able to determine the effect of paracetamol on prostaglandin synthesis
Sponsors
University of Copenhagen
Hvidovre University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
identical capsules containing Paracetamol and placebo is prepared by the pharmacy
Intervention model description
Randomised double blind placebo-controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age ≥ 18 years * Nondiabetic fasting plasma glucose (\< 7.0 mmol/L) at time of inclusion * BMI of 20-25 * Written informed consent
Exclusion criteria
* Haemoglobin \< 7.9 mmol/L * Pregnancy or breastfeeding * Significant gastrointestinal symptoms (e.g. dyspepsia, postprandial pain) * Use of medication that cannot be paused for 12 hours or any drug that affects gastric emptying, small intestinal motility, glucose absorption. * Use of paracetamol, NSAID, aspirin or similar within the previous week. * Evidence of drug abuse, consumption of tobacco in any form or daily consumption of more than 20g alcohol * History of gastrointestinal disease, including significant upper or lower gastrointestinal symptoms, pancreatitis, or previous gastrointestinal surgery including cholecystectomy (but not uncomplicated appendicectomy) * Participation in other research studies within the previous 3 months * Inability to give informed consent * Intolerance to any of the components of paracetamol and the meals used for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucagon-like peptide 1 | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glucose | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| Gastrin | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| Cholecystokinin | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| Glucose-dependent insulinotropic polypeptide (GIP) | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| C-peptide | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| Glucagon | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| Pancreatic polypeptide | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
| 3-OMG | From baseline samples (-15, 0 min) until the end of the meal test at t = 180min | Plasma concentration |
Countries
Denmark
Contacts
CONTACTSimon Veedfald, MD, PhD
PRINCIPAL_INVESTIGATORSimon Veedfald, MD, PhD
Department of BIomedical Scienes, University Copenhagen
Outcome results
None listed