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Sleep Disturbances and Biomarkers of Sarcopenic OBesity

Sleep Disturbances and Biomarkers of Sarcopenic OBesity: Insight Into Mechanisms of Prefrailty

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03175601
Acronym
SleSOB
Enrollment
100
Registered
2017-06-05
Start date
2017-06-30
Completion date
2018-07-31
Last updated
2017-06-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sarcopenic Obesity

Keywords

Sleep disturbances, Biomarkers, Prefrailty, Insulin resistance, Olfactory impairment, Multiplex array, Gait speed

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

Interventions

None listed

Sponsors

Niguarda Hospital
CollaboratorOTHER
Istituto di Fisiologia Clinica CNR
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
55 Years to 70 Years
Healthy volunteers
Yes

Inclusion criteria

* Obesity : body mass index ≥ 30 and \<40 kg/m2 * Written informed consent

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Prevalence of prefrailtyDay oneProportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity

Secondary

MeasureTime frameDescription
Screening for cognitive impairmentDay oneMini Mental State Examination (MMSE) score
Tissue accumulation of Advanced Glycation End-products (AGE)Day oneAGE Reader Score
Biomarkers of oxidative stressDay oneMalondyaldehyde, aminothiols
Inflammatory biomarkersDay oneCytokinesinterleukin-6, interleukin-1beta, tumour ecrosis Factor-alpha, neopterin
AdipokinesDay oneAdiponectin, leptin
Prevalence of sarcopeniaDay oneProportion 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)
Cardiometabolic risk profile: insulin resistanceDay oneHomeostatic Model Assessmenti (HOMA)-insulin resistance index
Cardiometabolic risk profile: fatty liverDay oneFatty liver index (FLI)
Olfactory function: Total Olfactory Score (TOS)Day oneSum of Olfactory Threshold, Identification, Discrimination scores
Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD)Day oneAnswer to screening question for iRBD
Sleep abnormalities: insomnia severityDay oneInsomnia Severity Index (ISI) score
Sleep abnormalities: daytime sleepinessDay oneEpworth Sleepiness Scale (ESS) score
Cardiac rhythm abnormalitiesDay oneAtrial fibrillation burden during 24 hour home monitoring
Cardiac dysautonomia: deep breathing testDay oneExpiratory/inspiratory ratio
Cardiac dysautonomia: lying to standing testDay oneLying-to standing ratio
Orthostatic hypotensionDay oneDrop ≥20 mmHg in systolic and/or ≥10 mmHg in diastolic blood pressure after 1 and 5 minutes of active standing
MyokinesDay oneMyostatin, irisin
Cardiometabolic risk profile: 10-year cardiovascular riskDay oneHeartSCORE

Countries

Italy

Contacts

Primary ContactRenata De Maria, MD
renata.demaria@ospedaleniguarda.it+390266101344
Backup ContactJonica Campolo, MSc
jonica.campolo@ospedaleniguarda.it+39026473407

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026