Cardiometabolic Health and Inflammatory Resolution

NCT ID: NCT04256330

Last Updated: 2025-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-01-23

Study Completion Date

2027-09-01

Brief Summary

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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).

Detailed Description

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Conditions

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Volunteers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Lean and metabolically healthy

No interventions assigned to this group

Lean and metabolically unhealthy

No interventions assigned to this group

Overweight and metabolically healthy

No interventions assigned to this group

Overweight and metabolically unhealthy

No interventions assigned to this group

Obese and metabolically healthy

No interventions assigned to this group

Obese and metabolically unhealthy

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Göteborg University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Gothenburg university

Gothenburg, Västra Götaland County, Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Emma Börgeson, PhD

Role: CONTACT

+46313423833

Per-Anders Jansson, MD, PhD

Role: CONTACT

+46313420000

Facility Contacts

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Emma Börgeson, PhD

Role: primary

+46313420000

Per-Anders Jansson, PhD, MD

Role: backup

+46313420000

Other Identifiers

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2019-04179

Identifier Type: -

Identifier Source: org_study_id

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