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RecruitingNCT07205510Updated Oct 3, 2025

Sarcopenia, Metabolic Diseases, and Integrated Aging Longitudinal Evaluation (SMILE)

An observational study in Sarcopenia, Metabolic Diseases and All-cause Mortality, sponsored by RenJi Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-10-03.

Sponsored by RenJi Hospital · Observational

From the registry’s dates

  • Started Dec 2020; still recruiting 5 years 10 months later.
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
10,000
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Sarcopenia
  • Metabolic Diseases
  • All-cause Mortality
  • Aging
  • Cardiometabolic Diseases

Keywords

  • Sarcopenia
  • Metabolic Diseases
  • Aging
  • All-cause mortality
  • Cardiometabolic Diseases
03

In context

Sarcopenia

1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 120 across 419 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

RenJi Hospital is the lead sponsor of 535 studies on the registry; 244 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

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.

Inclusion criteria

Adults aged 18 and over

Exclusion criteria

Exclusion Criteria:

  1. Does not cooperate in signing the informed consent form;
  2. Does not possess legal capacity;
  3. In a state of loss of consciousness;
  4. Suffering from severe mental illness, unable to communicate normally;
  5. The researcher believes that the subject has a disease that affects the assessment of results and is unsuitable for inclusion.
05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
10,000 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Interventions

  • Othernothing

    This is an observational study.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: From enrollment to the 5-year and 10-year follow-up visit.

Secondary outcomes

  1. 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.

    Time frame: At 5 and 10 years from the baseline visit.

  2. 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.

    Time frame: At 5 and 10 years from the baseline visit.

07

Study locations

1 of 1 sites recruiting
  • Department of Geriatrics, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
    Shanghai, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — Applicants must submit a specific research plan to the research initiator and apply to share the data thereafter.

Supporting information: Study protocol, Sap, Csr

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07205510
Lead sponsor
RenJi Hospital
Responsible party
Sponsor
First posted
Oct 3, 2025
Start date
Dec 1, 2020
Primary completion
Dec 31, 2040 (estimated)
Completion
Dec 31, 2040 (estimated)
Last update
Oct 3, 2025

Study contacts

融 黄, Ph.D
Contact
11084@renji.com
+862168383816

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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