跳至主要内容
临床试验/NCT03394469
NCT03394469Unknown不适用

Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Population of Adult Obese Patients

University Hospital, Clermont-Ferrand2 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2018年6月4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
800
试验地点
2
主要终点
Sarcopenia

研究概览

简要总结

This project aims first to determine the prevalence of sarcopenia in a population of obese people of extended age group (18-70 years). In a second step, the factors determining and / or predisposing to sarcopenic obesity will be identified as well as plasmatic and urinary biomarkers specific to this phenotype.

详细描述

Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

Biological collection to identify plasma, serum, genetic, urinary and faecal biomarkers associated with sarcopenic obesity

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Screening
盲法
None

盲法说明

No masking

入排标准

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

入选标准

  • Age: 18-70 years
  • Sex: men and women
  • Patient followed in clinical nutrition benefiting from a metabolic assessment for optimization of clinical and paraclinical management
  • Patient meeting the criteria of obesity defined by BMI> 30 kg / m²
  • Major patient with free, informed and signed consent
  • Patient covered by the social security scheme

排除标准

  • Patient with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
  • Patient with neuromuscular disease
  • Patient with a total inability to walk
  • Minor patient
  • Refusal of the patient to participate in the study
  • Pregnant or lactating women
  • Patient deprived of liberty or under guardianship.

研究组 & 干预措施

cohort

Other

Collection of clinical and paraclinical data (biological and anthropometric) for evaluation of sarcopenic obesity in obese patients.

干预措施: collection (Other)

结局指标

主要结局

Sarcopenia

时间窗: at day 1

The primary endpoint is sarcopenia (present / absent), defined using the muscle mass index (SMI) corresponding to = SM / Height², where the total muscle mass (SM) is calculated from validated equations. by Janssen et al in a population of men and women with a large age range (18-86 years) and adiposity (BMI: 16-48 kg / m integrating bio-impedancemetry data ( BIA).

次要结局

未报告次要终点

研究者

发起方
University Hospital, Clermont-Ferrand
申办方类型
Other
责任方
Sponsor

研究点 (2)

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