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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06390189
Other study ID # 1-10-72-102-23
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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