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NCT Number: NCT07205510

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

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)'.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Geriatrics, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.

Shanghai, China

Location status: Recruiting

Location contact

Rong Huang, Ph.D

CONTACT

[email protected]

+862168383816

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Adults aged 18 and over

Exclusion criteria

  • 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.

Treatment and study plan

nothing

Other

This is an observational study.

Primary outcomes

  1. 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.

Secondary outcomes

  1. cause-specific mortality

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

    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.

  2. Major adverse cardiovascular events

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

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

融 黄, Ph.D

CONTACT

[email protected]

+862168383816

Sponsors and collaborators

Lead sponsor

RenJi Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2040
Study completion
2040
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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