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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03175601
Other study ID # 422-102016
Secondary ID
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
Health authority
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

Study Design


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
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