NCT04256330RecruitingNot Applicable
Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)
Göteborg University1 site in 1 country200 target enrollmentStarted: January 23, 2020Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 200
- Locations
- 1
- Primary Endpoint
- Inflammatory status
Study Overview
Brief Summary
The aim of this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (>30.0 kg/m2).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Inflammatory status
Time Frame: 2027
The inflammatory status, defined as CRP levels and ability to respond to pro-resolving therapeutics, will be studied in all 6 groups
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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