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RecruitingNCT06380777Updated Apr 24, 2024

Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia

An observational study in Sarcopenia, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-24.

Sponsored by Peking Union Medical College Hospital · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
10,000
Ages
45 Years and older
Sex
All
01

Study summary

The goal of this observational study is to establish a digital diagnosis and treatment system for sarcopenia, integrating research outcomes into a unified approach encompassing a digital vaccine (early warning screening model), digital drug (intervention model associated with pathogenesis), and digital rehabilitation (preventive system combining early warning and treatment). This aims to create a digital visual tertiary prevention network for sarcopenia.

Research aims:

Evaluate the effectiveness of the digital vaccine through a cross-sectional epidemiological survey.

Establish a specialized cohort for sarcopenia through a longitudinal investigation, implementing the digital drug and digital rehabilitation interventions.

Participants will:

Engage in screening and assessment based on inclusion and exclusion criteria.

Be monitored longitudinally, with tailored interventions for those with muscle atrophy and regular follow-ups for at-risk individuals.

Key outcomes will focus on sarcopenia indicators, serum biomarkers, and clinical endpoints such as fracture rates, weakness classification, and quality of life.

02

Conditions studied

  • Sarcopenia

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03

In context

Sarcopenia

1,240 studies on the registry are indexed under Sarcopenia; 405 are open to participants now.

This study's planned enrollment of 10,000 is above the median of 120 across 433 observational studies indexed under Sarcopenia.

Browse Sarcopenia studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,148 studies on the registry; 474 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Browse Peking Union Medical College Hospital studies →

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

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

outpatient patients, inpatients, elderly population in elderly care institutions, and community registered elderly patients in the north part of China

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age ≥45 years;
  • meeting sarcopenia diagnostic criteria;
  • consent to participate in this study

Exclusion criteria

Exclusion Criteria:

  • Age \<45 years;
  • patients in acute phase of chronic illness;
  • infectious disease patients;
  • people who lack of independent mobility;
  • people who lack of communication or cognitive skills;
  • people who refusal to participate in this study
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
10,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples without dna
06

What researchers measure

Primary outcomes

  1. Appendicular skeletal muscle mass index

    Defined as muscle mass (Unit: kg/m2)

    Time frame: Through study completion, an average of 6weeks

Secondary outcomes

  1. Hand grip strength

    Defined as muscle strength (Unit: kg)

    Time frame: Through study completion, an average of 6weeks

  2. Gait speed

    Defined as physical performance (Unit: m/s)

    Time frame: Through study completion, an average of 6weeks

Other outcomes

  1. Concentration of insulin

    Serum insulin levels

    Time frame: Through study completion, an average of 6weeks

  2. Concentration of adiponectin

    Serum adiponectin levels

    Time frame: Through study completion, an average of 6weeks

  3. Concentration of leptin

    Serum leptin levels

    Time frame: Through study completion, an average of 6weeks

  4. Concentration of insulin like growth factor -1(IGF-1)

    Serum IGF-1 levels

    Time frame: Through study completion, an average of 6weeks

  5. Concentration of interleukin 18 (IL-18)

    Serum IL-18 levels

    Time frame: Through study completion, an average of 6weeks

  6. Concentration of tumor necrosis factor - α (TNF-α)

    Serum TNF-α levels

    Time frame: Through study completion, an average of 6weeks

  7. Concentration of TNF-like weak inducer of apoptosis (TWEAK)

    Serum TWEAK levels

    Time frame: Through study completion, an average of 6weeks

  8. Concentration of fibroblast growth factor -19 (FGF-19)

    Serum FGF-19 levels

    Time frame: Through study completion, an average of 6weeks

  9. Concentration of myostatin

    Serum myostatin levels

    Time frame: Through study completion, an average of 6weeks

  10. Concentration of chemoattractant protein-1 (MCP-1)

    Serum MCP-1 levels

    Time frame: Through study completion, an average of 6weeks

  11. Concentration of activin

    Serum activin levels

    Time frame: Through study completion, an average of 6weeks

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2023 (actual). Primary completion is estimated for Dec 2028, 63 months after the start.

Of 177 non-industry observational studies under Sarcopenia, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 63. This study's planned 63 months is above that.

Counting every sponsor, half of 180 studies reached it within 25 months; a quarter within 11 and three quarters within 56.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 6, 2024
First posted
Apr 24, 2024
StartActual
Sep 1, 2023
Primary completionEst.
Dec 31, 2028
CompletionEst.
Dec 31, 2028
Last update
Apr 24, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06380777
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Yu Kang, MD (professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Apr 24, 2024
Start date
Sep 1, 2023
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Apr 24, 2024

Study contacts

Yu Kang
Contact
yuk1997@sina.com
86 13801130457
Kang Yu
study director · Peking Union Medical College Hospital

Oversight

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

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