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REX: Cardiometabolic Health and Inflammatory Resolution

Sponsor
Göteborg University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04256330
Collaborator
(none)
200
Enrollment
1
Location
67.3
Anticipated Duration (Months)
3
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    200 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)
    Actual Study Start Date :
    Jan 23, 2020
    Anticipated Primary Completion Date :
    Dec 31, 2023
    Anticipated Study Completion Date :
    Sep 1, 2025

    Arms and Interventions

    Arm Intervention/Treatment
    Lean and metabolically healthy
    Lean and metabolically unhealthy
    Overweight and metabolically healthy
    Overweight and metabolically unhealthy
    Obese and metabolically healthy
    Obese and metabolically unhealthy

    Outcome Measures

    Primary Outcome Measures

    1. Inflammatory status [2025]

      The inflammatory status will be studied in all 6 groups.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Gothenburg university Gothenburg Vastra Gotaland Sweden 41669

    Sponsors and Collaborators

    • Göteborg University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Göteborg University
    ClinicalTrials.gov Identifier:
    NCT04256330
    Other Study ID Numbers:
    • 2019-04179
    First Posted:
    Feb 5, 2020
    Last Update Posted:
    Feb 5, 2020
    Last Verified:
    Feb 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Feb 5, 2020