Sarcopenic ObesitySleSOBNCT03175601
Sleep Disturbances and Biomarkers of Sarcopenic OBesity
An observational study of Sarcopenic Obesity, run by Istituto di Fisiologia Clinica CNR at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Sarcopenic Obesity
- How many people
- 100 participants
- Where
- 1 siteItaly
- Study dates
- Jun 2017to Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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 (http://www.inran.it/) (Protein 15%, Fat < 30%, carbohydrates 55/60% of which soluble 10-12 % and fiber 30 g die).
Who may be able to join
- Obesity : body mass index ≥ 30 and <40 kg/m2
- Written informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep Disturbances and Biomarkers of Sarcopenic OBesity: Insight Into Mechanisms of Prefrailty
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.
Read the 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
- Conditions
- Sarcopenic Obesity
- Keywords
- Sleep disturbances, Biomarkers, Prefrailty, Insulin resistance, Olfactory impairment, Multiplex array, Gait speed
- Medical subject headings
- Parasomnias, Insulin Resistance, Olfaction Disorders
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of prefrailty
Proportion of subjects presenting with one or more of reduced muscle mass, fatigue, weakness, slowness, and low physical activity
Measured: Day one
Secondary outcomes (18)
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)
Measured: Day one
Cardiometabolic risk profile: insulin resistance
Homeostatic Model Assessmenti (HOMA)-insulin resistance index
Measured: Day one
Cardiometabolic risk profile: fatty liver
Fatty liver index (FLI)
Measured: Day one
Cardiometabolic risk profile: 10-year cardiovascular risk
HeartSCORE
Measured: Day one
Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD)
Answer to screening question for iRBD
Measured: Day one
Sleep abnormalities: insomnia severity
Insomnia Severity Index (ISI) score
Measured: Day one
Sleep abnormalities: daytime sleepiness
Epworth Sleepiness Scale (ESS) score
Measured: Day one
Cardiac rhythm abnormalities
Atrial fibrillation burden during 24 hour home monitoring
Measured: Day one
Cardiac dysautonomia: deep breathing test
Expiratory/inspiratory ratio
Measured: Day one
Cardiac dysautonomia: lying to standing test
Lying-to standing ratio
Measured: Day one
Orthostatic hypotension
Drop ≥20 mmHg in systolic and/or ≥10 mmHg in diastolic blood pressure after 1 and 5 minutes of active standing
Measured: Day one
Olfactory function: Total Olfactory Score (TOS)
Sum of Olfactory Threshold, Identification, Discrimination scores
Measured: Day one
Screening for cognitive impairment
Mini Mental State Examination (MMSE) score
Measured: Day one
Tissue accumulation of Advanced Glycation End-products (AGE)
AGE Reader Score
Measured: Day one
Biomarkers of oxidative stress
Malondyaldehyde, aminothiols
Measured: Day one
Inflammatory biomarkers
Cytokinesinterleukin-6, interleukin-1beta, tumour ecrosis Factor-alpha, neopterin
Measured: Day one
Adipokines
Adiponectin, leptin
Measured: Day one
Myokines
Myostatin, irisin
Measured: Day one
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionMay 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenic ObesityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto di Fisiologia Clinica CNR
- Sponsor type
- University, hospital or other
- Collaborators
- Niguarda Hospital
- Responsible party
- Sponsor
- Investigators
- Maria Giovanna Trivella, MD, Principal investigator, Istituto di Fisiologia Clinica CNRJonica Campolo, MSc, Study director, Istituto di Fisiologia Clinica CNR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03175601
- Sponsor's protocol ID
- 422-102016
- Acronym
- SleSOB
- Status last verified
- Jun 2017
- First submitted
- 1 Jun 2017
- Last updated
- 6 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disturbances and Biomarkers of Sarcopenic OBesity: Insight Into Mechanisms of Prefrailty
- ClinicalTrials.gov ID
- NCT03175601
- Acronym / sponsor ID
- SleSOB / 422-102016
- Conditions
- Sarcopenic Obesity
- Keywords
- Sleep disturbances, Biomarkers, Prefrailty, Insulin resistance, Olfactory impairment, Multiplex array, Gait speed
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Istituto di Fisiologia Clinica CNRUniversity, hospital or other
- Collaborators
- Niguarda Hospital
- Study start
- Jun 2017 (estimated)
- Primary completion
- May 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 5 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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 (http://www.inran.it/) (Protein 15%, Fat < 30%, carbohydrates 55/60% of which soluble 10-12 % and fiber 30 g die).
Key inclusion criteria (2 listed)
- Obesity : body mass index ≥ 30 and <40 kg/m2
- Written informed consent
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
18 secondary outcomes
Prevalence of sarcopenia
Time frame: Day one
Cardiometabolic risk profile: insulin resistance
Time frame: Day one
Cardiometabolic risk profile: fatty liver
Time frame: Day one
Cardiometabolic risk profile: 10-year cardiovascular risk
Time frame: Day one
Sleep abnormalities: idiopathic REM Behaviour Disorder (iRBD)
Time frame: Day one
Sleep abnormalities: insomnia severity
Time frame: Day one
Sleep abnormalities: daytime sleepiness
Time frame: Day one
Cardiac rhythm abnormalities
Time frame: Day one
Cardiac dysautonomia: deep breathing test
Time frame: Day one
Cardiac dysautonomia: lying to standing test
Time frame: Day one
Orthostatic hypotension
Time frame: Day one
Olfactory function: Total Olfactory Score (TOS)
Time frame: Day one
Screening for cognitive impairment
Time frame: Day one
Tissue accumulation of Advanced Glycation End-products (AGE)
Time frame: Day one
Biomarkers of oxidative stress
Time frame: Day one
Inflammatory biomarkers
Time frame: Day one
Adipokines
Time frame: Day one
Myokines
Time frame: Day one
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Giovanna Trivella, MD principal investigator
Istituto di Fisiologia Clinica CNR
Jonica Campolo, MSc study director
Istituto di Fisiologia Clinica CNR
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenic Obesity, run by Istituto di Fisiologia Clinica CNR at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Renata De Maria, MD (+390266101344, renata.demaria@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of prefrailty (time frame: Day one). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2017.