Sarcopenia
Conditions
Interventions
Drug intervention group:A low-dose initiation and individualized stepwise titration regimen will be adopted. The starting dose of pegylated recombinant human growth hormone injection (PEG-rhGH) is 1 m
Sponsors
Fuzhou University Affiliated Provincial Hospital
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 65 to 85 years (inclusive), with no gender restriction; 2. Meet the 2025 diagnostic criteria of the Asian Working Group for Sarcopenia (AWGS): (1) Low muscle strength (handgrip strength < 28 kg for males, < 18 kg for females); (2) Low muscle mass (appendicular skeletal muscle mass index [ASMI] < 7.0 kg/m^2 for males, < 5.7 kg/m^2 for females, measured by bioelectrical impedance analysis [BIA]); 3. Serum IGF-1 level below the age- and sex-matched reference range mean (IGF-1 SDS < -0.5); 4. Able to ambulate independently (use of assistive devices permitted); 5. Voluntarily sign the informed consent form and be able to comply with study visit requirements.
Exclusion criteria
Exclusion criteria: 1. History of unstable angina, myocardial infarction, stroke, or transient ischemic attack within the past 6 months; 2. Chronic heart failure classified as Class III or IV according to the New York Heart Association (NYHA) functional classification; 3. Poorly controlled hypertension (as judged by the investigator); systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg; 4. History of malignancy within the past 5 years, or known active malignancy, or currently receiving anti-tumor therapy; 5. Prior history of definite pituitary disease (e.g., pituitary tumor, Cushing’s syndrome, etc.); 6. Presence of diseases or conditions that significantly affect body composition assessment or motor function testing, such as active arthralgia, uncontrolled thyroid dysfunction (hyperthyroidism or hypothyroidism), active rheumatoid arthritis, etc.; 7. Major surgery within the past 3 months, or presence of uncontrolled severe infection; 8. Use of other medications that may significantly affect muscle metabolism or body weight within the past 6 months, such as systemic glucocorticoids, testosterone, other anabolic steroids, growth hormone preparations, or GLP-1 receptor agonists; 9. Glycated hemoglobin (HbA1c) = 7.5% or fasting blood glucose > 8 mmol/L at screening; 10. Laboratory findings indicating abnormal liver or kidney function at screening (e.g., alanine aminotransferase or aspartate aminotransferase > 3 × upper limit of normal [ULN]; total bilirubin > 1.5 × ULN; creatinine > ULN); active liver disease; 11. History of chronic renal insufficiency (e.g., estimated glomerular filtration rate [eGFR] < 45 mL/min/1.73 m²); 12. Known allergy to the investigational drug, pegylated recombinant human growth hormone, or any of its excipients; 13. History of alcohol or substance abuse; 14. Planned major surgery during the study period; 15. Mental or cognitive impairment that precludes understanding of the study or adherence to the protocol; 16. Anorexia, with a weight loss of more than 5% within the past 6 months or a Simplified Nutritional Appetite Questionnaire (SNAQ) score < 14; 17. Participation in another interventional clinical trial within the past 3 months; 18. Any other condition that, in the investigator’s opinion, may increase the risk to the subject, interfere with the assessment of study outcomes, or affect the subject’s ability to complete the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Appendicular skeletal muscle mass index (ASMI);Handgrip strength; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gait speed;Five-times sit-to-stand test time;Short Physical Performance Battery (SPPB);Lean body mass (LBM);Body fat percentage (BFP);Quality of life score (SF-36);Safety assessment;IGF-1 level ; | — |
Countries
China
Contacts
Public ContactLin Chunjin
Fuzhou University Affiliated Provincial Hospital
Outcome results
None listed