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临床试验/NCT04238494
NCT04238494Unknown不适用

Muscle Multi-parametric NMR Imaging Development in Aged People With Sarcopenia or Frailty Syndrome; CLINical Study

University Hospital, Bordeaux2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年10月18日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
2
主要终点
Fat involution and trophicity in rectus femoris

研究概览

简要总结

Frailty is a multideterminant syndrome in which muscle function appears to play a central role. Muscle function depends on brain control, nutrition and perfusion. We hypothesized that multiparametric MRI assessment combined with comprehensive gerontological assessment (CGA) and routine biological assessment of inflammation in a sample of older people with and without diabetes will allow to explore on one side the possibilities of multi-parametric MRI muscle and brain imaging to describe the correlates of frailty and on the other side will describe the different muscle/brain alterations due to diabetes in frailty.

The main objective is to compare the lipid percent of the rectus femoris in frail and pre-frail older subjects and in non-frail older subjects.

详细描述

Frailty concept has been created to screen the older people at risk for dependency and to propose preventive intervention. Muscle function is at the centre of the concept and the majority of interventions proposed to reverse or to prevent frailty have targeted physical function. Anatomical and functional alteration of muscle, called sarcopenia is defined as a low skeletal muscle mass, a decrease in strength (dynapenia or sarcopenia is the age-associated loss of muscle strength that is not caused by neurologic or muscular diseases) and functional consequences such as low gait speed. Qualitative analysis should be associated with quantitative (mass) analysis in older subjects assessed for frailty. Muscle architecture, lipid and active tissue muscle content should be measured. Proton NMR imaging (MRI) can be used for this purpose. Brain changes were also reported to be associated with frailty. The study of structural changes associated with brain MRI alterations may better explain the frailty process.

Robust, frail and pre-frail subjects will be compared for clinical and MRI data. Grey matter volumes, white matter hyperintensities, diffusion tensor imaging data and muscle assessments relationships will be described After baseline assessment follow-up will be performed by phone calls after one month and after six months to record the number of falls and severity, the number of unscheduled hospitalization, the admission in institution for older people and death.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
70 Years 至 90 Years(Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Robust or frail or pre-frail with at least 25% frail and 25% pre-frail according to Frieds criteria
  • •Barthel index > or = 60/100
  • •With or without diabetes mellitus, 45 to 55 % with known diabetes mellitus
  • •With no contraindication to undergo an MRI examination

排除标准

  • •not willing to participate
  • •not able to give informed consent or to understand basic instruction due to any problem (sensorial, educational, language)
  • •without social insurance
  • •with a legal protection
  • •with significant cognitive alteration (MMSe<21/30 or in case of low literacy <19/30)
  • •with a recent (2 month period) severe event: hospitalization, sepsis, stroke even with complete recovery, trauma
  • •with stroke sequelae (motor, speech)

研究组 & 干预措施

Frail/prefrail

Experimental

Fried's criteria >3 = frail, 1 or 2 = prefrail The 5 Fried criteria mainly target the muscle function: low muscle strength, decreased physical activity and low gait speed. One refers to depressive symptoms with the use of 2 CES-D (Centre for Epidemiologic Studies - Depression Scale) questions and one to nutrition with the weight loss criteria. The second most famous definition of frailty was developed by ROCKWOOD and MITNISIKI (2). It describes frailty as the accumulation of deficits including cognitive, functional and social alterations

干预措施: Nuclear magnetic resonance (NMR) (Diagnostic Test)

non frail

Other

No Fried's criteria

干预措施: Nuclear magnetic resonance (NMR) (Diagnostic Test)

结局指标

主要结局

Fat involution and trophicity in rectus femoris

时间窗: day 1

percentage of the rectus femoris lipid of both leg (dominant and non-dominant) in frail and pre-frail older subject and in non-frail older subjects (MRI with T1)

次要结局

  • measure the cystatin-C and creatinine rate(day 1)
  • description of brain by MRI(day 1)
  • Evaluation of inflammation grade(day 1)
  • measure the myostatin rate(day 1)
  • measure the serum interleukin IL-1b and IL-18 rate(day 1)

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (2)

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