Inflammatory Resolution in Cardiometabolic Health and Disease

NCT06390189 | Recruiting DMC

• 1 other identifier: 1-10-72-102-23
• Study Type: observational
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflammation; Obesity; Cardiovascular Diseases

Outcome Measures

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.

  September 2028

Secondary Outcomes (1)

• Systemic low-grade inflammation measurement in different phenotypes

  September 2028

Study Arms (6)

Lean and metabolically healthy

Lean and metabolically unhealthy

Overweight and metabolically healthy

Overweight and metabolically unhealthy

Obese and metabolically healthy

Obese and metabolically unhealthy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Aarhus: lead

Study Sites (1)

Steno Diabetes Center Aarhus, Aarhus University Hospital

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Inflammation; Obesity; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Central Study Contacts

Emma Börgeson, PhD

CONTACT

+4593522984; emma.borgeson@biomed.au.dk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 30, 2024
• Study Start: May 7, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2028
• Last Updated: June 28, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)