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临床试验/NCT04630132
NCT04630132Unknown不适用

Renal Ageing-sarcopenia Network: a Combined Genetic, Immunological and Psychological Approach to Dissect Frailty

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 1,500 人开始时间: 2017年3月25日最近更新:
适应症

试验速览

阶段
不适用
入组人数
1,500
试验地点
1
主要终点
Correlation between Frailty and Klotho polymorphism, assessed by Fried Classification: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5)

研究概览

简要总结

Frailty is a syndrome in which the accumulation of small, individually insignificant deficits leads to heightened vulnerability to adverse events and predisposes to potential catastrophic decompensation.

Objective of this study is to clarify the underlying genetic and immunological mechanisms responsible of frailty condition focused on: i. nephrosclerosis ageing kidney phenotype related to salt effects on immunosystem, ii. immunological aspect of sarcopenia, iii. psychological disorder related to immunosystem activation, iv. detection of new biomarkers of frailty.

详细描述

The cross-sectional, observational cohort study include 1500 subjects (age >65 years) subdivided in 750 cases and 750 controls according to frailty.

Subjects who met the following criteria are included: 1) older than 65; 2) able to walk 500 m without assistance; 3) a Mini-Mental State Examination (MMSE) score <18; and 4) no severe health problems (eg, uncontrolled hypertension, recent upper or lower extremity fractures, myocardial infarction within the past 1 year).

According to definition for the 'phenotype' of frailty (cases) is as follows: presence of three or more of the following features:

  1. Decreased grip strength
  2. Self-reported exhaustion
  3. Unintentional weight loss of more than 4.5 kg over the past year
  4. Slow walking speed
  5. Low physical activity

The investigators select as control subjects with presence of less than 1 criteria . All the control subjects are evaluated by the same protocol than the cases. Subjects will be collected in collaboration with senior housing (RSA) of Milano city, country clubs, social club for elderly, and elderly university. The study will be approved by the Ethics Committee of ASL of Milano city and at individual centers by local ethical committees. All the study participants signed informed consent. At the baseline evaluation, a large amount of data is collected. First, the participants completed a battery of self-reported questionnaires concerning the demographic characteristics, psychosocial adjustment, quality of life, and health condition, in the presence of a trained psychologist in order to clarify any doubts. Second, an expert in physical education and adapted physical activity for older adults administered physical tests. Finally, people with expertise in the eld of ergonomics take anthropometric measurements. Data collection is always carried out in the same order and individually for each participant.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
65 Years 至 —(Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 65 years
  • Male and female patients
  • Patients able to walk > 500 m without assistance
  • MMSE < 18
  • No severe health problems (Uncontrolled hypertension, recent upper or lower extremity fractures, myocardial infarction within the past 1 year).

排除标准

  • Severe cardiological or pulmonary disease (NYHA IV, Gold IV)
  • Intracranial interventions
  • Dying patients (palliative situation)
  • Not enough language skills
  • Non-consenting patients
  • Participation in another prospective intervention study for study inclusion or throughout the study period.

结局指标

主要结局

Correlation between Frailty and Klotho polymorphism, assessed by Fried Classification: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5)

时间窗: 3 years

Verifying the role of the polymorphism of the Klotho gene in the development of the "fragility" phenotype in elderly subjects.

次要结局

  • Correlation between Frailty and Klotho (KL), Adducine (ADD1, ADD2 and ADD3), Lanosterol and other polymorphisms, assessed by Fried Classification: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5)(3 years)
  • Correlation between Frailty and plasmatic values of endogenous ouabain, Klotho and plasma cytokines, assessed by Fried Classification: non-frail (score 0), pre-frail (score 1-2) and frail (score 3-5)(3 years)
  • Creation of a multidisciplinary frailty score, based on the outcomes of the study(3 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Paolo Manunta

Professor

IRCCS San Raffaele

研究点 (1)

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