Sarcopenia
Conditions
Brief summary
This is a single center, prospective biomarker study to evaluate serum levels of TWEAK and expression levels of TWEAK and Fn14 in muscle biopsies from patients with sarcopenia as well as healthy, physically active controls.
Interventions
PROCEDUREOutpatient Muscle Biopsy
Outpatient Muscle Biopsy involving skeletal muscle sample collected from the vastus lateralis muscle
Sponsors
Biogen
University of Florida
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
To be eligible to participate in this study, all candidates must meet the following eligibility criteria at Baseline or at the time point specified in the individual eligibility criterion listed: All Participants 1\. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information in accordance with national and local subject privacy regulations Subjects with Sarcopenia 1. Men and postmenopausal women of 65 years of age or older 2. Gait speed measured over 4 meters of \<1.0 m/s OR grip strength \< 26 kg for men or \< 16 kg for women. 3. Appendicular skeletal muscle adjusted for BMI by DXA ≤ 0.789 for men and ≤ 0.512 for women. 4. Weigh at least 40kg; 5. Self-reported difficulty climbing 10 steps OR walking outside on level ground for 1/4 mile Healthy Controls 1. Men and postmenopausal women of 65 Years of age or older 2. Body mass index (BMI) between 18.5 and 30 kg/m2 inclusive at the time of Screening 3. Measures of Physical Performance and Lean Mass exceed thresholds defined for Sarcopenia group. 4. ≥ 150 minutes/week moderate-intensity physical activity OR regular engagement in resistance training ≥ 2 days/week 5. Willing to maintain a consistent diet and pattern of physical activity for the duration of the study
Exclusion criteria
Candidates will be excluded from study entry if any of the following
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum concentration of TWEAK at day 1 | Day 1 |
Secondary
| Measure | Time frame |
|---|---|
| Relative expression levels of TWEAK mRNA in muscle biopsy at day 1 | Day 1 |
| Relative expression levels of Fn14 mRNA in muscle biopsy at day 1 | Day 1 |
| Correlation between serum TWEAK levels and muscle strength | Day 1 |
| Incidence of AEs and SAEs | Screening through Day 14 |
Countries
United States
Outcome results
None listed