Inflammatory Resolution in Cardiometabolic Health and Disease

NCT ID: NCT06390189

Last Updated: 2024-06-28

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

240 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-07

Study Completion Date

2028-09-01

Brief Summary

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The specific aim of this study is to determine molecular pathways that differentiate metabolically healthy vs unhealthy human phenotypes, and to investigate the therapeutic potential of pro-resolving lipids. Investigators will recruit volunteers that are metabolically healthy or unhealthy that fall within three BMI ranges: lean (18.-24.9 kg/m2), overweight (25.0-29.9 kg/m2) and obese (\>30.0 kg/m2). Investigators hypothesize that metabolically healthy individuals have a superior endogenous capacity to regulate an inflammatory/resolving response.

Detailed Description

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Conditions

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Inflammation Obesity Cardiovascular Diseases

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
* Men and women over the age of 18 are included.

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 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 (e.g., 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

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, , Denmark

Site Status RECRUITING

Countries

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Denmark

Central Contacts

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Emma Börgeson, PhD

Role: CONTACT

+4593522984

Facility Contacts

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Emma Börgeson, PhD

Role: primary

+4593522984

Other Identifiers

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1-10-72-102-23

Identifier Type: -

Identifier Source: org_study_id

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