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Cardiometabolic Health and Inflammatory Resolution (REX)

G

Göteborg University

Status

Enrolling

Conditions

Volunteers

Study type

Observational

Funder types

Other

Identifiers

NCT04256330
2019-04179

Details and patient eligibility

About

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).

Enrollment

200 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.

Trial design

200 participants in 6 patient groups

Lean and metabolically healthy
Lean and metabolically unhealthy
Overweight and metabolically healthy
Overweight and metabolically unhealthy
Obese and metabolically healthy
Obese and metabolically unhealthy

Trial contacts and locations

1

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Central trial contact

Emma Börgeson, PhD; Per-Anders Jansson, MD, PhD

Data sourced from clinicaltrials.gov

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