Investigating inflammation in cardiometabolic health
Inflammatory Resolution in Cardiometabolic Health and Disease - an Aarhus Based Cohort
University of Aarhus · NCT06390189
This study is trying to see how inflammation affects people’s heart and metabolic health by comparing blood samples from lean, overweight, and obese volunteers.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 240 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | University of Aarhus (other) |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Aarhus) |
| Trial ID | NCT06390189 on ClinicalTrials.gov |
What this trial studies
This observational study aims to identify molecular pathways that distinguish metabolically healthy individuals from those who are unhealthy, focusing on the role of pro-resolving lipids in inflammation. Volunteers will be recruited based on their BMI, which will categorize them into lean, overweight, or obese groups. The hypothesis is that metabolically healthy individuals possess a better ability to manage inflammatory responses. The study will involve analyzing blood samples to assess inflammatory markers and lipid profiles.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with a BMI greater than 18.5 kg/m2, categorized as either metabolically healthy or unhealthy.
Not a fit: Patients with chronic inflammation, those on immunosuppressive drugs, or individuals regularly using medications that affect inflammatory resolution may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to new therapeutic strategies for managing inflammation in cardiometabolic diseases.
How similar studies have performed: While the specific approach of this study may be novel, previous studies have shown that understanding inflammation can lead to significant advancements in treating cardiometabolic conditions.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Aarhus
- Steno Diabetes Center Aarhus, Aarhus University Hospital — Aarhus, Denmark (RECRUITING)
Study contacts
- Study coordinator: Emma Börgeson, PhD
- Email: emma.borgeson@biomed.au.dk
- Phone: +4593522984
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Inflammation, Obesity, Cardiovascular Diseases