Sleep Disturbances and Biomarkers of Sarcopenic OBesity: Insight Into Mechanisms of Prefrailty
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Prevalence of prefrailty
研究概览
简要总结
The general objective of this study is to identify biomarkers of sleep quality, sarcopenia, insulin resistance, oxidative stress and inflammation associated with prefrailty in middle-aged and elderly obese subjects through the integrated study of sleep patterns, functional cardiovascular testing, olfactory function and circulating molecules.
Results from the SleSOB study will contribute to identify molecular and functional determinants of prefrailty, to allow early targeted interventions and will have important implications for empowerment of elderly citizens to self-management of preventive measures and healthy lifestyle.
详细描述
Frailty, an age-related state of low physiological reserve and high vulnerability to stressors, impacts on health, functional independence, quality of life and survival; its early detection at the prefrailty stage offers the opportunity for preventive intervention. Sarcopenia, a hallmark of frailty, may occur in association with obesity and worsen functional deterioration. Obesity is strongly associated with insulin resistance and is a risk factor for both cardiometabolic diseases and cognitive impairment. Adipose tissue exerts autocrine and paracrine functions leading to chronic low-grade inflammation and increased oxidative stress that, in turn, decrease muscle density and precipitate muscle strength loss. Sleep disturbances and sarcopenia might be causally related through dysregulation of glucose metabolism and disruption of the secretory pattern of hormones involved in muscle metabolism.
Main objective:
To establish among young-elderly obese subjects the prevalence of prefrailty as defined by presence of ≥1 of reduced muscle mass, fatigue, weakness, slowness, and low physical activity (Fried's criteria)
Secondary objectives:
- To assess prevalence and severity of sarcopenia as defined by reduced muscle mass coupled with decreased muscle strength and /or reduced functional capacity
- To establish the cardiometabolic risk profile and its correlation with vitamin D
- To determine type and extent of sleep abnormalities by validated questionnaires and their association with prefrailty
- To assess the extent of sympathetic imbalance, arrhythmia burden and olfactory impairment
- To determine patterns of biomarkers of oxidative stress, inflammatory cytokines, adipokines, myokines, tissue damage and remodeling and correlation with prefrailty and insulin resistance.
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
- 55 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Obesity : body mass index ≥ 30 and <40 kg/m2
- •Written informed consent
排除标准
- •Diabetes requiring insulin treatment
- •Stage IV chronic kidney dysfunction (estimated glomerular filtration rate <15 ml/min)
- •Liver dysfunction (AST- ALT x 2 times upper normalcy range)
- •Active neoplasms
- •Claustrophobia
- •Psychiatric morbidity or any other condition that impairs the ability to give informed consent
结局指标
主要结局
Prevalence of prefrailty
时间窗: Day one
Proportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity
次要结局
- Cardiometabolic risk profile: fatty liver(Day one)
- Tissue accumulation of Advanced Glycation End-products (AGE)(Day one)
- Myokines(Day one)
- Screening for cognitive impairment(Day one)
- Cardiometabolic risk profile: 10-year cardiovascular risk(Day one)
- Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD)(Day one)
- Sleep abnormalities: daytime sleepiness(Day one)
- Cardiac dysautonomia: deep breathing test(Day one)
- Cardiometabolic risk profile: insulin resistance(Day one)
- Prevalence of sarcopenia(Day one)
- Sleep abnormalities: insomnia severity(Day one)
- Cardiac rhythm abnormalities(Day one)
- Orthostatic hypotension(Day one)
- Adipokines(Day one)
- Cardiac dysautonomia: lying to standing test(Day one)
- Olfactory function: Total Olfactory Score (TOS)(Day one)
- Biomarkers of oxidative stress(Day one)
- Inflammatory biomarkers(Day one)