Sleep Disturbances and Biomarkers of Sarcopenic OBesity

Sarcopenic Obesity Clinical Trial

— SleSOB  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03175601
• Other study ID #: 422-102016
• Status: Not yet recruiting
• Phase: N/A
• First received: June 1, 2017
• Last updated: June 2, 2017
• Start date: June 2017
• Est. completion date: July 2018

Study information

• Verified date: June 2017
• Source: Istituto di Fisiologia Clinica CNR
• Contact: Renata De Maria, MD
• Phone: +390266101344
• Email: renata.demaria[@]ospedaleniguarda.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: July 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dyssomnias
• Obesity
• Parasomnias
• Sarcopenic Obesity
• Sleep Wake Disorders

Locations

Country	Name	City	State
Italy	Istituto di Fisiologia Clinica del CNR UOS Milano	Milano

Sponsors (2)

Lead Sponsor	Collaborator
Istituto di Fisiologia Clinica CNR	Niguarda Hospital

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of prefrailty	Proportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity	Day one
Secondary	Prevalence of sarcopenia	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)	Day one
Secondary	Cardiometabolic risk profile: insulin resistance	Homeostatic Model Assessmenti (HOMA)-insulin resistance index	Day one
Secondary	Cardiometabolic risk profile: fatty liver	Fatty liver index (FLI)	Day one
Secondary	Cardiometabolic risk profile: 10-year cardiovascular risk	HeartSCORE	Day one
Secondary	Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD)	Answer to screening question for iRBD	Day one
Secondary	Sleep abnormalities: insomnia severity	Insomnia Severity Index (ISI) score	Day one
Secondary	Sleep abnormalities: daytime sleepiness	Epworth Sleepiness Scale (ESS) score	Day one
Secondary	Cardiac rhythm abnormalities	Atrial fibrillation burden during 24 hour home monitoring	Day one
Secondary	Cardiac dysautonomia: deep breathing test	Expiratory/inspiratory ratio	Day one
Secondary	Cardiac dysautonomia: lying to standing test	Lying-to standing ratio	Day one
Secondary	Orthostatic hypotension	Drop =20 mmHg in systolic and/or =10 mmHg in diastolic blood pressure after 1 and 5 minutes of active standing	Day one
Secondary	Olfactory function: Total Olfactory Score (TOS)	Sum of Olfactory Threshold, Identification, Discrimination scores	Day one
Secondary	Screening for cognitive impairment	Mini Mental State Examination (MMSE) score	Day one
Secondary	Tissue accumulation of Advanced Glycation End-products (AGE)	AGE Reader Score	Day one
Secondary	Biomarkers of oxidative stress	Malondyaldehyde, aminothiols	Day one
Secondary	Inflammatory biomarkers	Cytokinesinterleukin-6, interleukin-1beta, tumour ecrosis Factor-alpha, neopterin	Day one
Secondary	Adipokines	Adiponectin, leptin	Day one
Secondary	Myokines	Myostatin, irisin	Day one