NCT07205510

Brief 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)'.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,000

participants targeted

Target at P75+ for all trials

Timeline
179mo left

Started Dec 2020

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress27%
Dec 2020Dec 2040

Study Start

First participant enrolled

December 1, 2020

Completed
4.7 years until next milestone

First Submitted

Initial submission to the registry

August 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 3, 2025

Completed
15.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2040

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2040

Last Updated

October 3, 2025

Status Verified

September 1, 2025

Enrollment Period

20.1 years

First QC Date

August 28, 2025

Last Update Submit

September 25, 2025

Conditions

Keywords

SarcopeniaMetabolic DiseasesAgingAll-cause mortalityCardiometabolic Diseases

Outcome Measures

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.

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

Secondary Outcomes (2)

  • cause-specific mortality

    At 5 and 10 years from the baseline visit.

  • Major adverse cardiovascular events

    At 5 and 10 years from the baseline visit.

Interventions

nothingOTHER

This is an observational study.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Adults aged 18 and over

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, China

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Serum, whole blood, urine, and fecal specimens

MeSH Terms

Conditions

SarcopeniaMetabolic Diseases

Condition Hierarchy (Ancestors)

Muscular AtrophyNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and SymptomsNutritional and Metabolic Diseases

Central Study Contacts

融 黄, Ph.D

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 28, 2025

First Posted

October 3, 2025

Study Start

December 1, 2020

Primary Completion (Estimated)

December 31, 2040

Study Completion (Estimated)

December 31, 2040

Last Updated

October 3, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will share

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

Shared Documents
STUDY PROTOCOL, SAP, CSR

Locations