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RecruitingNCT06390189RESOLVE AUUpdated Jun 28, 2024

Inflammatory Resolution in Cardiometabolic Health and Disease

An observational study in Inflammation, Obesity and Cardiovascular Diseases, sponsored by University of Aarhus. Recruiting at 1 site in Denmark. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-28.

Sponsored by University of Aarhus · Observational

From the registry’s dates

  • Started May 2024; still recruiting 2 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
240
Ages
18 Years to 75 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Inflammation
  • Obesity
  • Cardiovascular Diseases
03

In context

Cardiovascular Diseases

4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.

This study's planned enrollment of 240 is below the median of 573 across 1,485 observational studies indexed under Cardiovascular Diseases.

Browse Cardiovascular Diseases studies →

Lead sponsor

University of Aarhus is the lead sponsor of 1,274 studies on the registry; 183 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Individuals that contact the investigators (via phone or email) and express an interest in participating in the study will be invited to an information visit, after which the individual has at least 24 hours to consider their participation. For those that are interested in the study, the investigators then proceed to schedule visit 1-5.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
240 participants (estimated)
Patient registry
No

Groups and cohorts

  • Lean and metabolically healthy
  • Lean and metabolically unhealthy
  • Overweight and metabolically healthy
  • Overweight and metabolically unhealthy
  • Obese and metabolically healthy
  • Obese and metabolically unhealthy
06

What researchers measure

Primary outcomes

  1. Inflammation and resolution status measurements in different metabolic phenotypes

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

    Time frame: September 2028

Secondary outcomes

  1. Systemic low-grade inflammation measurement in different phenotypes

    Measurement of plasma C-reactive protein

    Time frame: September 2028

07

Study locations

1 of 1 sites recruiting
  • Steno Diabetes Center Aarhus, Aarhus University Hospital
    Aarhus, 8200, Denmark
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 28, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06390189
Lead sponsor
University of Aarhus
Responsible party
Sponsor
First posted
Apr 30, 2024
Start date
May 7, 2024
Primary completion
Sep 1, 2026 (estimated)
Completion
Sep 1, 2028 (estimated)
Last update
Jun 28, 2024

Study contacts

Emma Börgeson, PhD
Contact
emma.borgeson@biomed.au.dk
+4593522984

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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