Clinical trial NCT06380777: Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia
Official title: Establishment and Application of a Digital Diagnosis and Treatment System for Sarcopenia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Sarcopenia
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 10000
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief 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.


Eligibility criteria: Inclusion Criteria:

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

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

Primary outcomes:
measure: Appendicular skeletal muscle mass index
timeFrame: Through study completion, an average of 6weeks
Secondary outcomes:
measure: Hand grip strength
timeFrame: Through study completion, an average of 6weeks
measure: Gait speed
timeFrame: Through study completion, an average of 6weeks
Other outcomes:
measure: Concentration of insulin
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of adiponectin
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of leptin
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of insulin like growth factor -1(IGF-1)
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of interleukin 18 (IL-18)
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of tumor necrosis factor - α (TNF-α)
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of TNF-like weak inducer of apoptosis (TWEAK)
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of fibroblast growth factor -19 (FGF-19)
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of myostatin
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of chemoattractant protein-1 (MCP-1)
timeFrame: Through study completion, an average of 6weeks
measure: Concentration of activin
timeFrame: Through study completion, an average of 6weeks
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Kang Yu
role: STUDY_DIRECTOR
References: