Inflammatory Resolution in Cardiometabolic Health and Disease
Recruiting · NCT06390189 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Aarhus
View the official record on ClinicalTrials.gov →What this trial is about
The specific aim of this study is to determine molecular pathways that differentiate metabolically healthy vs unhealthy human phenotypes, and to investigate the therapeutic potential of pro-resolving lipids. Investigators will recruit volunteers that are metabolically healthy or unhealthy that fall within three BMI ranges: lean (18.-24.9 kg/m2), overweight (25.0-29.9 kg/m2) and obese (\>30.0 kg/m2). Investigators hypothesize that metabolically healthy individuals have a superior endogenous capacity to regulate an inflammatory/resolving response.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
Yes - healthy volunteers may be accepted
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
Inclusion criteria
- Informed signed consent has been obtained from the volunteer.
- The volunteer has a BMI greater than 18.5 kg/m2
- Men and women over the age of 18 are included.
Exclusion criteria
- The study staff contacting a potential participant perceives that the individual has difficulty understanding the information.
- An MD determines that the individual is on too many medications to participate.
- The individual takes a medication that is approved by the MD, but he/she is not willing or not able to wait with any potential morning medication until after their fasted blood-draw.
- The individual states that they have increased bleeding tendency or are using anti-coagulant (blood thinning) medication.
- The individual has some form of chronic inflammation.
- The individual regularly uses medication that affects inflammatory resolution (e.g., low-dose aspirin).
- The individual uses immunosuppressive drugs (e.g., methotrexate).
- The individual regularly consumes fish oils (omega 3).
- The individual has significant gastrointestinal problems.
- The individual smokes or uses chewing tobacco.
- The individual has been drinking alcohol two days before the study visit.
- The individual has tattoos or body piercings on the forearms and / or the stomach that can affect the examination.
- The individual does not follow instructions given in the research study.
Where it is running
1 location listed.
- Steno Diabetes Center Aarhus, Aarhus University Hospital - Aarhus, Denmark