Establishment and Application of Digital Diagnosis and Treatment System for Sarcopenia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia

• Study Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: Yu Kang; Phone Number: 86 13801130457; Email: yuk1997@sina.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • Peking Union Medical College Hospital
      • Contact: Kang Yu, MD; Phone Number: +86 010-69155550; Email: yuk1997@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• 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

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Appendicular skeletal muscle mass index	Defined as muscle mass (Unit: kg/m2)	Through study completion, an average of 6weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hand grip strength	Defined as muscle strength (Unit: kg)	Through study completion, an average of 6weeks
Gait speed	Defined as physical performance (Unit: m/s)	Through study completion, an average of 6weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Concentration of insulin	Serum insulin levels	Through study completion, an average of 6weeks
Concentration of adiponectin	Serum adiponectin levels	Through study completion, an average of 6weeks
Concentration of leptin	Serum leptin levels	Through study completion, an average of 6weeks
Concentration of insulin like growth factor -1(IGF-1)	Serum IGF-1 levels	Through study completion, an average of 6weeks
Concentration of interleukin 18 (IL-18)	Serum IL-18 levels	Through study completion, an average of 6weeks
Concentration of tumor necrosis factor - α (TNF-α)	Serum TNF-α levels	Through study completion, an average of 6weeks
Concentration of TNF-like weak inducer of apoptosis (TWEAK)	Serum TWEAK levels	Through study completion, an average of 6weeks
Concentration of fibroblast growth factor -19 (FGF-19)	Serum FGF-19 levels	Through study completion, an average of 6weeks
Concentration of myostatin	Serum myostatin levels	Through study completion, an average of 6weeks
Concentration of chemoattractant protein-1 (MCP-1)	Serum MCP-1 levels	Through study completion, an average of 6weeks
Concentration of activin	Serum activin levels	Through study completion, an average of 6weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Study Director: Kang Yu, Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: April 6, 2024
• First Submitted That Met QC Criteria: April 21, 2024
• First Posted (Actual): April 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 21, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Sarcopenia
• Other Study ID Numbers: DDT system for sarcopenia

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No