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Recruiting NCT04256330

Cardiometabolic Health and Inflammatory Resolution

— Observational Volunteers

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Volunteers. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Sweden
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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).

Primary outcome measures

  • Inflammatory status [Time frame: 2027]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Study design

Observational model
Cohort

Study locations

Sweden · 1 center
  • Gothenburg university — Gothenburg

Identifiers

NCT: NCT04256330 · 2019-04179

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗