Cardiometabolic Health and Inflammatory Resolution (REX)

Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)

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 Overview

• Status: Recruiting
• Conditions: Volunteers

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Emma Börgeson, PhD; Phone Number: +46313423833; Email: emma.borgeson@wlab.gu.se
• Study Contact Backup: Name: Per-Anders Jansson, MD, PhD; Phone Number: +46313420000; Email: Per-Anders.Jansson@wlab.gu.se

Study Locations

• Sweden
  • Vastra Gotaland
    • Gothenburg, Vastra Gotaland, Sweden, 41669
      • Recruiting
      • Gothenburg University
      • Contact: Emma Börgeson, PhD; Phone Number: +46313420000; Email: emma.borgeson@wlab.gu.se
      • Contact: Per-Anders Jansson, PhD, MD; Phone Number: +46313420000; Email: Per-Anders.Jansson@wlab.gu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

6

Cohorts and Interventions

Group / Cohort
Lean and metabolically healthy
Lean and metabolically unhealthy
Overweight and metabolically healthy
Overweight and metabolically unhealthy
Obese and metabolically healthy
Obese and metabolically unhealthy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Göteborg University

Study record dates

Study Major Dates

• Study Start (Actual): January 23, 2020
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: February 3, 2020
• First Submitted That Met QC Criteria: February 3, 2020
• First Posted (Actual): February 5, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 5, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 2019-04179

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No