Understanding how inflammation affects heart and metabolic health
Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)
This study looks at how inflammation affects heart and metabolic health in people of different weights to see how it impacts their overall health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Göteborg University Academic / other |
| Drugs / interventions | methotrexate |
| Locations | 1 site (Gothenburg, Västra Götaland County) |
| Trial ID | NCT04256330 on ClinicalTrials.gov |
What this trial studies
This observational study aims to explore the relationship between inflammatory resolution and cardiometabolic health in individuals with varying body mass indices (BMIs). Participants will include lean, overweight, and obese volunteers who meet specific eligibility criteria. The study will assess how inflammation impacts health outcomes in these groups, focusing on their metabolic profiles and cardiovascular health. Data will be collected through blood draws and health assessments to analyze the effects of inflammation on cardiometabolic conditions.
Who should consider this trial
Good fit: Ideal candidates for this study are volunteers aged 18 and older with a BMI greater than 18.5 kg/m2.
Not a fit: Patients with chronic inflammation, those on immunosuppressive drugs, or individuals with increased bleeding tendencies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into how managing inflammation may improve heart and metabolic health in diverse populations.
How similar studies have performed: While this study explores a specific aspect of inflammation and cardiometabolic health, similar studies have shown promising results in understanding the role of inflammation in various health 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 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 is younger than 18 years (relevant for the FAINT-1 and FAINT-2 cohorts) * 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 (eg, 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
Gothenburg, Västra Götaland County
- Gothenburg university — Gothenburg, Västra Götaland County, Sweden (Recruiting)
Study contacts
- Study coordinator: Emma Börgeson, PhD
- Email: emma.borgeson@wlab.gu.se
- Phone: +46313423833
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.