Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia

NCT06380777 | Recruiting

• 1 other identifier: DDT system for sarcopenia
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Sarcopenia

Outcome Measures

Primary Outcomes (1)

• Appendicular skeletal muscle mass index

  Defined as muscle mass (Unit: kg/m2)

  Through study completion, an average of 6weeks

Secondary Outcomes (2)

• Hand grip strength

  Through study completion, an average of 6weeks

• Gait speed

  Through study completion, an average of 6weeks

Other Outcomes (11)

• Concentration of insulin

  Through study completion, an average of 6weeks

• Concentration of adiponectin

  Through study completion, an average of 6weeks

• Concentration of leptin

  Through study completion, an average of 6weeks

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and stool

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Study Officials

• Kang Yu

  Peking Union Medical College Hospital

  STUDY DIRECTOR

Central Study Contacts

Yu Kang

CONTACT

86 13801130457; yuk1997@sina.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: April 6, 2024
• First Posted: April 24, 2024
• Study Start: September 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 24, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)