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Sleep Disturbances and Biomarkers of Sarcopenic OBesity (SleSOB)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03175601
Recruitment Status : Unknown
Verified June 2017 by Istituto di Fisiologia Clinica CNR.
Recruitment status was:  Not yet recruiting
First Posted : June 5, 2017
Last Update Posted : June 6, 2017
Niguarda Hospital
Information provided by (Responsible Party):
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.

Condition or disease
Sarcopenic Obesity

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

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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sleep Disturbances and Biomarkers of Sarcopenic OBesity: Insight Into Mechanisms of Prefrailty
Estimated Study Start Date : June 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sleep Disorders

Primary Outcome Measures :
  1. Prevalence of prefrailty [ Time Frame: Day one ]
    Proportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity

Secondary Outcome Measures :
  1. Prevalence of sarcopenia [ Time Frame: 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)

  2. Cardiometabolic risk profile: insulin resistance [ Time Frame: Day one ]
    Homeostatic Model Assessmenti (HOMA)-insulin resistance index

  3. Cardiometabolic risk profile: fatty liver [ Time Frame: Day one ]
    Fatty liver index (FLI)

  4. Cardiometabolic risk profile: 10-year cardiovascular risk [ Time Frame: Day one ]

  5. Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD) [ Time Frame: Day one ]
    Answer to screening question for iRBD

  6. Sleep abnormalities: insomnia severity [ Time Frame: Day one ]
    Insomnia Severity Index (ISI) score

  7. Sleep abnormalities: daytime sleepiness [ Time Frame: Day one ]
    Epworth Sleepiness Scale (ESS) score

  8. Cardiac rhythm abnormalities [ Time Frame: Day one ]
    Atrial fibrillation burden during 24 hour home monitoring

  9. Cardiac dysautonomia: deep breathing test [ Time Frame: Day one ]
    Expiratory/inspiratory ratio

  10. Cardiac dysautonomia: lying to standing test [ Time Frame: Day one ]
    Lying-to standing ratio

  11. Orthostatic hypotension [ Time Frame: Day one ]
    Drop ≥20 mmHg in systolic and/or ≥10 mmHg in diastolic blood pressure after 1 and 5 minutes of active standing

  12. Olfactory function: Total Olfactory Score (TOS) [ Time Frame: Day one ]
    Sum of Olfactory Threshold, Identification, Discrimination scores

  13. Screening for cognitive impairment [ Time Frame: Day one ]
    Mini Mental State Examination (MMSE) score

  14. Tissue accumulation of Advanced Glycation End-products (AGE) [ Time Frame: Day one ]
    AGE Reader Score

  15. Biomarkers of oxidative stress [ Time Frame: Day one ]
    Malondyaldehyde, aminothiols

  16. Inflammatory biomarkers [ Time Frame: Day one ]
    Cytokinesinterleukin-6, interleukin-1beta, tumour ecrosis Factor-alpha, neopterin

  17. Adipokines [ Time Frame: Day one ]
    Adiponectin, leptin

  18. Myokines [ Time Frame: Day one ]
    Myostatin, irisin

Biospecimen Retention:   Samples Without DNA
Serum, plasma and urine samples

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   55 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Middle-aged and young-old obese subjects will be enrolled at a specialised nutrition clinic. Subjects will be on a maintenance weight management program including lifestyle advice and diet based on the principles of the Modern Mediterranean Diet Pyramid (variety in food choices, seasonality and spices to flavor dishes). The diet is modified to avoid high caloric food and distributed in 3 main meals and 2 healthy snacks during the day to provide a caloric intake of 28-30 kcal/die/kg body weight and macronutrient breakdown as recommended by INRAN ( (Protein 15%, Fat < 30%, carbohydrates 55/60% of which soluble 10-12 % and fiber 30 g die).

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03175601

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Contact: Renata De Maria, MD +390266101344
Contact: Jonica Campolo, MSc +39026473407

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Istituto di Fisiologia Clinica del CNR UOS Milano
Milano, Italy, 20162
Sponsors and Collaborators
Istituto di Fisiologia Clinica CNR
Niguarda Hospital
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Principal Investigator: Maria Giovanna Trivella, MD Istituto di Fisiologia Clinica CNR
Study Director: Jonica Campolo, MSc Istituto di Fisiologia Clinica CNR

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Responsible Party: Istituto di Fisiologia Clinica CNR Identifier: NCT03175601     History of Changes
Other Study ID Numbers: 422-102016
First Posted: June 5, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Istituto di Fisiologia Clinica CNR:
Sleep disturbances
Insulin resistance
Olfactory impairment
Multiplex array
Gait speed
Additional relevant MeSH terms:
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Sleep Wake Disorders
Nutrition Disorders
Body Weight
Signs and Symptoms
Nervous System Diseases
Mental Disorders
Neurologic Manifestations