SarcopeniaNCT07205510
Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)
An observational study of Sarcopenia and Metabolic Diseases, run by RenJi Hospital at 1 site in China.
Trial summary
This study aims to establish an ambispective cohort platform centered on the pathological axis of "sarcopenia-metabolic disorders-aging progression", integrating multimodal data including demographic characteristics, lifestyle factors, clinical phenotypes, laboratory tests, medical imaging, and biospecimens. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sarcopenia, Metabolic Diseases, All-cause Mortality
- What is being tested?
- nothing
- How many people
- 10,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2020to 31 Dec 2040
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients visiting the Geriatrics Department of Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, who were aged 18 years and above.
Who may be able to join
- Adults aged 18 and over
Who cannot join
- Does not cooperate in signing the informed consent form;
- Does not possess legal capacity;
- In a state of loss of consciousness;
- Suffering from severe mental illness, unable to communicate normally;
- The researcher believes that the subject has a disease that affects the assessment of results and is unsuitable for inclusion.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Geriatrics, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
Shanghai
Rong Huang, Ph.D, +862168383816, 11084@renji.com
About this study
This study aims to establish an ambispective cohort platform centered on the pathological axis of "sarcopenia-metabolic disorders-aging progression", integrating multimodal data including demographic characteristics, lifestyle factors, clinical phenotypes, laboratory tests, medical imaging, and biospecimens. Namely 'Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)'.
Read the detailed description
Sarcopenia is an age-related syndrome characterized by progressive decline in skeletal muscle mass, strength, and function. Traditionally regarded as a consequence of aging, it not only impairs physical mobility, nutritional status, and activities of daily living but also significantly increases the risk of falls, frailty, disability, and subsequent hospitalization. Furthermore, sarcopenia is associated with prolonged hospital stays, elevated postoperative complications, and even premature mortality, imposing substantial economic and healthcare burdens on patients, families, and society.
Recent studies have revealed a complex interplay between sarcopenia and metabolic disorders (e.g., diabetes, dyslipidemia, and obesity), which collectively accelerate the aging process and elevate the risks of cardiovascular events, cardiovascular mortality, and all-cause mortality. Therefore, early identification of changes in muscle mass and function, along with preventive measures against sarcopenia, is crucial for mitigating long-term disease risks. However, strategies for early detection of muscle aging progression and at-risk populations remain to be further elucidated.
This study aims to establish an ambispective cohort platform centered on the pathological axis of "sarcopenia-metabolic disorders-aging progression", integrating multimodal data including demographic characteristics, lifestyle factors, clinical phenotypes, laboratory tests, medical imaging, and biospecimens. Namely 'Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)'. By combining retrospective and prospective cohort analyses, we will longitudinally track individual health data and conduct in-depth exploration of interaction mechanisms. The objectives are to unravel the dynamic interplay between sarcopenia and metabolic diseases in aging. Assess their mid-to-long-term impact on cardiovascular events and all-cause mortality, and develop novel strategies for early identification and risk stratification.
The findings will provide a robust theoretical foundation and key technological support for precision interventions in sarcopenia, delaying functional decline, and optimizing health management in aging populations. This study holds significant implications for addressing chronic disease risks exacerbated by population aging and alleviating associated socioeconomic burdens.
- Being tested
- nothing
- Keywords
- Sarcopenia, Metabolic Diseases, Aging, All-cause mortality, Cardiometabolic Diseases
- Medical subject headings
- Sarcopenia, Metabolic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nothingOther
This is an observational study.
What is being measured
The primary outcome is the main question the study is designed to answer.
all-cause mortality
Collect information on all-cause mortality of patients through hospital medical records, telephone follow-ups, outpatient follow-ups, etc., in order to assess the combined effects and underlying mechanisms of sarcopenia, metabolic diseases, and aging on all-cause mortality.
Measured: From enrollment to the 5-year and 10-year follow-up visit.
Secondary outcomes (2)
cause-specific mortality
Collect information on cause-specific mortality of patients through hospital medical records, telephone follow-ups, outpatient follow-ups, etc., in order to assess the combined effects and underlying mechanisms of sarcopenia, metabolic diseases, and aging on cause-specific mortality. In-depth exploration of the role of sarcopenia, metabolic diseases, and aging in the severe outcomes of mortality caused by various diseases.
Measured: At 5 and 10 years from the baseline visit.
Major adverse cardiovascular events
Through medical records within the hospital, telephone follow-ups, outpatient follow-ups, we will collect detailed information on the occurrence of new major adverse cardiovascular events (cardiovascular death, myocardial infarction, stroke) in the study subjects during the follow-up period. The aim is to analyze the impact, mechanisms, and interactions of sarcopenia, metabolic diseases, and aging on the occurrence and development of these adverse events.
Measured: At 5 and 10 years from the baseline visit.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start1 Dec 2020
- Primary completion31 Dec 2040 (estimated)
- Study completion31 Dec 2040 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- More trials run by RenJi HospitalThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 10,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205510
- Sponsor's protocol ID
- LY2025-239-A
- Status last verified
- Sep 2025
- First submitted
- 28 Aug 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Applicants must submit a specific research plan to the research initiator and apply to share the data thereafter.
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)
- ClinicalTrials.gov ID
- NCT07205510
- Acronym / sponsor ID
- LY2025-239-A
- Keywords
- Sarcopenia, Metabolic Diseases, Aging, All-cause mortality, Cardiometabolic Diseases
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 10,000 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2020 (actual)
- Primary completion
- 31 Dec 2040 (estimated)
- Study completion
- 31 Dec 2040 (estimated)
- First posted
- 3 Oct 2025 (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.
This study aims to establish an ambispective cohort platform centered on the pathological axis of "sarcopenia-metabolic disorders-aging progression", integrating multimodal data including demographic characteristics, lifestyle factors, clinical phenotypes, laboratory tests, medical imaging, and biospecimens. Namely 'Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)'.
Detailed description
Sarcopenia is an age-related syndrome characterized by progressive decline in skeletal muscle mass, strength, and function. Traditionally regarded as a consequence of aging, it not only impairs physical mobility, nutritional status, and activities of daily living but also significantly increases the risk of falls, frailty, disability, and subsequent hospitalization. Furthermore, sarcopenia is associated with prolonged hospital stays, elevated postoperative complications, and even premature mortality, imposing substantial economic and healthcare burdens on patients, families, and society.
Recent studies have revealed a complex interplay between sarcopenia and metabolic disorders (e.g., diabetes, dyslipidemia, and obesity), which collectively accelerate the aging process and elevate the risks of cardiovascular events, cardiovascular mortality, and all-cause mortality. Therefore, early identification of changes in muscle mass and function, along with preventive measures against sarcopenia, is crucial for mitigating long-term disease risks. However, strategies for early detection of muscle aging progression and at-risk populations remain to be further elucidated.
This study aims to establish an ambispective cohort platform centered on the pathological axis of "sarcopenia-metabolic disorders-aging progression", integrating multimodal data including demographic characteristics, lifestyle factors, clinical phenotypes, laboratory tests, medical imaging, and biospecimens. Namely 'Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)'. By combining retrospective and prospective cohort analyses, we will longitudinally track individual health data and conduct in-depth exploration of interaction mechanisms. The objectives are to unravel the dynamic interplay between sarcopenia and metabolic diseases in aging. Assess their mid-to-long-term impact on cardiovascular events and all-cause mortality, and develop novel strategies for early identification and risk stratification.
The findings will provide a robust theoretical foundation and key technological support for precision interventions in sarcopenia, delaying functional decline, and optimizing health management in aging populations. This study holds significant implications for addressing chronic disease risks exacerbated by population aging and alleviating associated socioeconomic burdens.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients visiting the Geriatrics Department of Renji Hospital affiliated with Shanghai Jiao Tong University School of Medicine, who were aged 18 years and above.
Key inclusion criteria (1 listed)
- Adults aged 18 and over
Key exclusion criteria (5 listed)
- Does not cooperate in signing the informed consent form;
- Does not possess legal capacity;
- In a state of loss of consciousness;
- Suffering from severe mental illness, unable to communicate normally;
- The researcher believes that the subject has a disease that affects the assessment of results and is unsuitable for inclusion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nothingThis is an observational study. | Other | – |
Primary outcome
all-cause mortality
Time frame: From enrollment to the 5-year and 10-year follow-up visit.
Collect information on all-cause mortality of patients through hospital medical records, telephone follow-ups, outpatient follow-ups, etc., in order to assess the combined effects and underlying mechanisms of sarcopenia, metabolic diseases, and aging on all-cause mortality.
2 secondary outcomes
cause-specific mortality
Time frame: At 5 and 10 years from the baseline visit.
Major adverse cardiovascular events
Time frame: At 5 and 10 years from the baseline visit.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Yes. Applicants must submit a specific research plan to the research initiator and apply to share the data thereafter.
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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.
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 Sarcopenia and Metabolic Diseases, run by RenJi Hospital at 1 site in China.
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 1 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 3 Oct 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact 融 黄, Ph.D (+862168383816, 11084@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
all-cause mortality (time frame: From enrollment to the 5-year and 10-year follow-up visit.). 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 3 Oct 2025.