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)'.

Study Overview

• Status: Recruiting
• Conditions: Metabolic Diseases; Sarcopenia; Aging; All-cause Mortality; Cardiometabolic Diseases
• Intervention / Treatment: Other: nothing

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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: 融 黄, Ph.D; Phone Number: +862168383816; Email: 11084@renji.com

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Department of Geriatrics, Renji Hospital, School of Medicine, Shanghai Jiaotong University, Shanghai, China.
    • Contact: Rong Huang, Ph.D; Phone Number: +862168383816; Email: 11084@renji.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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.

Description

Inclusion Criteria:

Adults aged 18 and over

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From enrollment to the 5-year and 10-year follow-up visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	At 5 and 10 years from the baseline visit.

Collaborators and Investigators

• Sponsor: RenJi Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Estimated): December 31, 2040
• Study Completion (Estimated): December 31, 2040

Study Registration Dates

• First Submitted: August 28, 2025
• First Submitted That Met QC Criteria: September 25, 2025
• First Posted (Estimated): October 3, 2025

Study Record Updates

• Last Update Posted (Estimated): October 3, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Aging; Sarcopenia; Metabolic Diseases; All-cause mortality; Cardiometabolic Diseases
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Sarcopenia; Metabolic Diseases
• Other Study ID Numbers: LY2025-239-A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Applicants must submit a specific research plan to the research initiator and apply to share the data thereafter.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No