Cardiometabolic Health and Inflammatory Resolution

Volunteers Clinical Trial

— REX  

Official title:

Cardiometabolic Health and Inflammatory Resolution (Kardiometabol hälsa Och Inflammatorisk Resolution)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04256330
• Other study ID #: 2019-04179
• Status: Recruiting
• Start date: January 23, 2020
• Est. completion date: September 1, 2025

Study information

• Verified date: February 2020
• Source: Göteborg University
• Contact: Emma Börgeson, PhD
• Phone: +46313423833
• Email: emma.borgeson[@]wlab.gu.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of this study is to determine how inflammatory resolution impacts cardiometabolic health and disease in subjects that are either lean (18.5-24.9 kg/m2), overweight (25.0-29.9 kg/m2) or obese (>30.0 kg/m2).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 1, 2025
• Est. primary completion date: December 31, 2023
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Informed signed consent has been obtained from the volunteer.

• The volunteer has a BMI greater than 18.5 kg/m2

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 is younger than 18 years (relevant for the FAINT-1 and FAINT-2 cohorts)

• 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 (eg, 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

• Volunteers

Locations

Country	Name	City	State
Sweden	Gothenburg university	Gothenburg	Vastra Gotaland

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inflammatory status	The inflammatory status will be studied in all 6 groups.	2025