Cardiometabolic Health and Inflammatory Resolution

NCT04256330 | Recruiting

• 1 other identifier: 2019-04179
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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).

Conditions

Volunteers

Outcome Measures

Primary Outcomes (1)

• Inflammatory status

  The inflammatory status, defined as CRP levels and ability to respond to pro-resolving therapeutics, will be studied in all 6 groups

  2027

Study Arms (6)

Lean and metabolically healthy

Lean and metabolically unhealthy

Overweight and metabolically healthy

Overweight and metabolically unhealthy

Obese and metabolically healthy

Obese and metabolically unhealthy

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects are recruited either via open adds of after having indicated in previous study registers that they are interested in participating as volunteers in future studies.

You may qualify if:

• Informed signed consent has been obtained from the volunteer.
• The volunteer has a BMI greater than 18.5 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Göteborg University: lead

Study Sites (1)

Gothenburg university

Gothenburg, Västra Götaland County, 41669, Sweden

RECRUITING

Central Study Contacts

Emma Börgeson, PhD

CONTACT

+46313423833; emma.borgeson@wlab.gu.se

Per-Anders Jansson, MD, PhD

CONTACT

+46313420000; Per-Anders.Jansson@wlab.gu.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 3, 2020
• First Posted: February 5, 2020
• Study Start: January 23, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027
• Last Updated: May 8, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)