Inflammatory Resolution in Cardiometabolic Health and Disease

Recruiting

• Conditions: Obesity; Inflammation; Cardiovascular Diseases

• Registration Number: NCT06390189
• Lead Sponsor: University of Aarhus

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-04
• Study First Submitted: 2024-04-19
• Study First Submitted QC: 2024-04-25
• Study First Posted: 2024-04-30
• Study Start: 2024-05-07
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-28
• Primary Completion: 2026-09-01
• Study Completion: 2028-09-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Inflammation and resolution status measurements in different metabolic phenotypes	September 2028	Quantifiable inflammatory resolution by measurement of IL-6 cytokine levels in the acute vs the resolving phase of blister formation.

Secondary Outcome Measures

Name	Time	Method
Systemic low-grade inflammation measurement in different phenotypes	September 2028	Measurement of plasma C-reactive protein

Trial Locations

Locations (1)

Steno Diabetes Center Aarhus, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark