Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia

Sarcopenia Clinical Trial

Official title:

Establishment and Application of a Digital Diagnosis and Treatment System for Sarcopenia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06380777
• Other study ID #: DDT system for sarcopenia
• Status: Recruiting
• Start date: September 1, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: April 2024
• Source: Peking Union Medical College Hospital
• Contact: Yu Kang
• Phone: 86 13801130457
• Email: yuk1997[@]sina.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Sarcopenia

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Concentration of insulin	Serum insulin levels	Through study completion, an average of 6weeks
Other	Concentration of adiponectin	Serum adiponectin levels	Through study completion, an average of 6weeks
Other	Concentration of leptin	Serum leptin levels	Through study completion, an average of 6weeks
Other	Concentration of insulin like growth factor -1(IGF-1)	Serum IGF-1 levels	Through study completion, an average of 6weeks
Other	Concentration of interleukin 18 (IL-18)	Serum IL-18 levels	Through study completion, an average of 6weeks
Other	Concentration of tumor necrosis factor - a (TNF-a)	Serum TNF-a levels	Through study completion, an average of 6weeks
Other	Concentration of TNF-like weak inducer of apoptosis (TWEAK)	Serum TWEAK levels	Through study completion, an average of 6weeks
Other	Concentration of fibroblast growth factor -19 (FGF-19)	Serum FGF-19 levels	Through study completion, an average of 6weeks
Other	Concentration of myostatin	Serum myostatin levels	Through study completion, an average of 6weeks
Other	Concentration of chemoattractant protein-1 (MCP-1)	Serum MCP-1 levels	Through study completion, an average of 6weeks
Other	Concentration of activin	Serum activin levels	Through study completion, an average of 6weeks
Primary	Appendicular skeletal muscle mass index	Defined as muscle mass (Unit: kg/m2)	Through study completion, an average of 6weeks
Secondary	Hand grip strength	Defined as muscle strength (Unit: kg)	Through study completion, an average of 6weeks
Secondary	Gait speed	Defined as physical performance (Unit: m/s)	Through study completion, an average of 6weeks