Inflammatory Resolution in Cardiometabolic Health and Disease

Obesity Clinical Trial

— RESOLVE AU  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06390189
• Other study ID #: 1-10-72-102-23
• Status: Not yet recruiting
• Start date: May 1, 2024
• Est. completion date: September 1, 2028

Study information

• Verified date: April 2024
• Source: University of Aarhus
• Contact: Emma Börgeson, PhD
• Phone: +4593522984
• Email: emma.borgeson[@]biomed.au.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: September 1, 2028
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Inflammation
• Obesity

Locations

Country	Name	City	State
Denmark	Steno Diabetes Center Aarhus, Aarhus University Hospital	Aarhus

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	inflammatory status	Quantifiable inflammatory resolution by measurement of IL-6 cytokine levels in the acute vs the resolving phase of blister formation.	September 2028