Sleep Disturbances and Biomarkers of Sarcopenic OBesity
- Conditions
- Sarcopenic Obesity
- Registration Number
- NCT03175601
- Lead Sponsor
- Istituto di Fisiologia Clinica CNR
- Brief Summary
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.
- Detailed Description
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.
Study design:
Eligible subjects will attend the clinic in the morning in the fasting state to undergo
* blood samples collection for routine and specific biochemistry;
* anthropometric measurements: height, weight, body mass index, waist and hip circumference;
* assement of sarcopenia: muscle strength, gait speed, muscle mass by biomimpedentiometric assessment (BIA) and air displacement pletismography (BODPOD);
* glucose metabolism biomarker as tissue accumulation of advanced glycation endproducts (AGE);
* sympathetic activation;
* interview for medical history and comorbidity registration;
* screening for cognitive impairment;
* sleep pattern analysis through questionnaires;
* olfactory assessment.
A wearable system (Win@home, CE0434) for 24 h recording of rhythm, circadian heart rate, respiratory rate and oxygen saturation, posture and physical activity will be applied to each subject for the subsequent 24 hours
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- Obesity : body mass index ≥ 30 and <40 kg/m2
- Written informed consent
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Prevalence of prefrailty Day one Proportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity
- Secondary Outcome Measures
Name Time Method Cardiac dysautonomia: deep breathing test Day one Expiratory/inspiratory ratio
Screening for cognitive impairment Day one Mini Mental State Examination (MMSE) score
Cardiometabolic risk profile: fatty liver Day one Fatty liver index (FLI)
Tissue accumulation of Advanced Glycation End-products (AGE) Day one AGE Reader Score
Myokines Day one Myostatin, irisin
Cardiometabolic risk profile: 10-year cardiovascular risk Day one HeartSCORE
Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD) Day one Answer to screening question for iRBD
Sleep abnormalities: daytime sleepiness Day one Epworth Sleepiness Scale (ESS) score
Cardiometabolic risk profile: insulin resistance Day one Homeostatic Model Assessmenti (HOMA)-insulin resistance index
Prevalence of sarcopenia Day one Proportion of subjects presenting with reduced muscle mass (by gender-specific cut offs ) coupled with decreased muscle strength (men ≤ 32 kg, women ≤ 21 kg and/or reduced gait speed (\<0.8 mt/sec on a 4 mt course)
Sleep abnormalities: insomnia severity Day one Insomnia Severity Index (ISI) score
Cardiac rhythm abnormalities Day one Atrial fibrillation burden during 24 hour home monitoring
Orthostatic hypotension Day one Drop ≥20 mmHg in systolic and/or ≥10 mmHg in diastolic blood pressure after 1 and 5 minutes of active standing
Adipokines Day one Adiponectin, leptin
Cardiac dysautonomia: lying to standing test Day one Lying-to standing ratio
Olfactory function: Total Olfactory Score (TOS) Day one Sum of Olfactory Threshold, Identification, Discrimination scores
Biomarkers of oxidative stress Day one Malondyaldehyde, aminothiols
Inflammatory biomarkers Day one Cytokinesinterleukin-6, interleukin-1beta, tumour ecrosis Factor-alpha, neopterin
Trial Locations
- Locations (1)
Istituto di Fisiologia Clinica del CNR UOS Milano
🇮🇹Milano, Italy