Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT01355861
Eligibility Criteria:
Inclusion Criteria:
Adult, ambulatory males \> 60 years old (n=30) will be recruited for this proposed study. Participant inclusion criteria also includes having clinically significant sarcopenia based on the body composition assessment showing an aLM that is \< 2 SD below the mean values of a young adult reference group using DEXA scanning.
Exclusion Criteria:
Exclusion criteria include BMI scores \> 30 or a Mini-Mental Status exam score of \< 22. The second tier of screening will include the following blood tests, obtained between 8-9 AM, following a 12-hour overnight fast: CBC, routine chemistry profile (e.g., glucose, kidney and liver function tests). Veterans with an elevated fasting blood glucose by WHO criteria (FBG \>110 mg/dl), triglyceride levels \> 200 mg/dL, and/or known DM, or abnormalities of other routine blood tests (i.e., \> 2 SD beyond normal) will be excluded from the study. Uncontrolled cardiovascular disease, non-ambulatory status, evidence of a major disease exacerbation over the last six months, and current participation in a supervised exercise program (minimum of three months, twice per week) would also preclude participation in this study.
Healthy Volunteers:
True
Sex:
MALE
Minimum Age:
60 Years
Maximum Age:
79 Years
Study:
NCT01355861
Study Brief:
Protocol Section:
NCT01355861