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Recruiting

NCT Number: NCT06390189

Inflammatory Resolution in Cardiometabolic Health and Disease

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.

Recruiting

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, 8200, Denmark

Location status: Recruiting

Location contact

Emma Börgeson, PhD

CONTACT

[email protected]

+4593522984

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Inflammation and resolution status measurements in different metabolic phenotypes

    Time frame: September 2028

    Quantifiable inflammatory resolution by measurement of IL-6 cytokine levels in the acute vs the resolving phase of blister formation.

Secondary outcomes

  1. Systemic low-grade inflammation measurement in different phenotypes

    Time frame: September 2028

    Measurement of plasma C-reactive protein

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Börgeson, PhD

CONTACT

[email protected]

+4593522984

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

Inflammatory Resolution in Cardiometabolic Health and Disease - an Aarhus Based Cohort

Acronym: RESOLVE AU

Important dates

Study start
2024
Primary completion
2026
Study completion
2028
First posted
Apr 30, 2024
Registry last updated
Jun 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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