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临床试验/NCT06390189
NCT06390189招募中不适用

Inflammatory Resolution in Cardiometabolic Health and Disease - an Aarhus Based Cohort

University of Aarhus1 个研究点 分布在 1 个国家目标入组 240 人开始时间: 2024年5月7日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
240
试验地点
1
主要终点
Inflammation and resolution status measurements in different metabolic phenotypes

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Inflammation and resolution status measurements in different metabolic phenotypes

时间窗: September 2028

Quantifiable inflammatory resolution by measurement of IL-6 cytokine levels in the acute vs the resolving phase of blister formation.

次要结局

  • Systemic low-grade inflammation measurement in different phenotypes(September 2028)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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