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NCT Number: NCT06380777

Establishment and Application of 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.

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Key information

Conditions

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

Age range

45 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Kang Yu, MD

CONTACT

[email protected]

+86 010-69155550

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Appendicular skeletal muscle mass index

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

    Defined as muscle mass (Unit: kg/m2)

Secondary outcomes

  1. Hand grip strength

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

    Defined as muscle strength (Unit: kg)

  2. Gait speed

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

    Defined as physical performance (Unit: m/s)

Other outcomes

  1. Concentration of insulin

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

    Serum insulin levels

  2. Concentration of adiponectin

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

    Serum adiponectin levels

  3. Concentration of leptin

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

    Serum leptin levels

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

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

    Serum IGF-1 levels

  5. Concentration of interleukin 18 (IL-18)

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

    Serum IL-18 levels

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

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

    Serum TNF-α levels

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

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

    Serum TWEAK levels

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

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

    Serum FGF-19 levels

  9. Concentration of myostatin

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

    Serum myostatin levels

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

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

    Serum MCP-1 levels

  11. Concentration of activin

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

    Serum activin levels

Study contacts

Contact information is provided by the study sponsor or research team.

Yu Kang

CONTACT

[email protected]

86 13801130457

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Apr 24, 2024
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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