Sarcopenic Obesity: Estimation of Prevalence and Identification of Clinical and Biological Determinants in a Cohort of Adult Obese Patients and Longitudinal Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- To estimate the prevalence of sarcopenia in a population of adult subjects with obesity, at baseline and at 5 and 10 years.
研究概览
简要总结
Context: Obesity, defined as excessive body fat, can lead to disability and loss of autonomy. If there is concomitant quantitative and qualitative muscle loss, sarcopenic obesity (SO) is suspected in this context. Although this clinical entity was defined several years ago, it is only very recently that precise assessment criteria have been established for screening and diagnosing this pathology (Donini et al. 2022).
Defined by the ESPEN/EASO consensus, SO has various consequences for health, particularly in terms of mobility and worsening of co-morbidities. It is therefore necessary to screen for SO, to determine its prevalence in the general population and to identify the determining factors in the loss of muscle mass during obesity. Most studies on the prevalence of sarcopenic obesity focus on the elderly population, bearing in mind that the prevalence of this syndrome in the elderly will increase rapidly as a result of the shift in the incidence of obesity from adults to this population in the coming decades.
The aim of this project is to determine the prevalence and determining or predisposing factors for sarcopenic obesity in a population of obese people in a broad age range (18-70 years).
Longitudinal follow-up of this cohort is planned in order to assess multifactorial changes (body composition, muscle function and physical performance) at 5 and 10 years after their inclusion in the OBESAR-2 study. In addition, patients who have undergone bariatric surgery will also be followed in the shorter term to analyse the phenotypic changes induced by rapid weight loss on muscle loss.
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
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
- 否
入选标准
- •Age: 18-70
- •Sex: men and women
- •Clinical nutrition patient receiving a metabolic assessment to optimise clinical and paraclinical management
- •Patient meeting obesity criteria defined by BMI > 30 kg/m².
- •Patient of legal age who has given free, informed and signed consent
- •Patient covered by social security
- •Non-inclusion criteria :
- •Patients with cancer or severe chronic disease (renal failure, respiratory failure, liver failure)
- •Patients with neuromuscular disease
- •Patient with total walking disability
- •Patients who are minors
- •Patient refusing to take part in the study
- •Pregnant or breast-feeding women
- •Under guardianship, curatorship, deprived of liberty or under court protection
- •Patient who has taken part in the OBESAR study
排除标准
- 未提供
结局指标
主要结局
To estimate the prevalence of sarcopenia in a population of adult subjects with obesity, at baseline and at 5 and 10 years.
时间窗: Day 1 / 5 years /10 years
The primary endpoint is the presence of sarcopenic obesity at inclusion, 5 years and 10 years post-inclusion, assessed according to the latest current recommendations, i.e. impaired muscle function and impaired body composition (Donini et al. 2022). A patient presents with sarcopenic obesity when there is an alteration in muscle function AND an alteration in body composition. For impaired muscular function, strength measured with the handgrip is considered pathological when it is less than 27kg for men and less than 16kg for women. Altered body composition is considered to exist when fat mass is greater than 39, 41 and 43% for women aged between 20 and 39, 40 and 59, and 60 and 79 respectively, and greater than 26, 29 and 31% for men aged between 20 and 39, 40 and 59, and 60 and 79 respectively, AND SMM/W (Skeletal Muscle Mass/Weight) is less than 37% in men and 27.6% in women.
次要结局
- % of patients with the factors associated with sarcopenia(Day 1 / 5 years /10 years)
- concentration of biomarkers in a group of obese patients with sarcopenia using the biobank.(Day 1 / 5 years /10 years)
- Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system.(Day 1 / 5 years /10 years)
- % change of parameters measured to identify the group at risk of accelerated decline(5 years /10 years)
- % of evolution of biomarkers(Day 1 / 5 years /10 years)
- % of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients.(Day 1 / 5 years /10 years)
- % of patients with the factors associated with sarcopenia in the subgroup of patients undergoing bariatric surgery.(Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years])
- concentration of biomarkers in a group of obese patients with sarcopenia using the biobank in the subgroup of patients undergoing bariatric surgery.(Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years])
- Evaluate the degree of severity of sarcopenic obesity over time using the ESPEN/EASO consensus staging system in the subgroup of patients undergoing bariatric surgery.(Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years])
- % of evolution of biomarkers in the subgroup of patients undergoing bariatric surgery.(Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years)
- % of risk of various health problems (diabetes, hypertension, etc.) between sarcopenic and non-sarcopenic patients in the subgroup of patients undergoing bariatric surgery.(Day 1 /Day of surgery/ 6 months after surgery/ 12 months after surgery/ 5 years /10 years])