TABLE 1.
Study design and timing of procedures.
| TIME ON TREATMENT (weeks): | 0a | 1 | 6–8 | 16 |
|---|---|---|---|---|
| PROCEDURES: | ||||
| Group assignment RAPA/placebod | 1b,2c | |||
| Physical exam, history | 1,2 | 1,2 | 1,2 | 1 |
| RAPA level | 1,2 | 2 | 1 | |
| Complete blood count | 1,2 | 1,2 | 1 | |
| Metabolic profile | 1,2 | 1,2 | 1 | |
| Fasting blood sugar (glucose) | 1,2 | 1,2 | 1 | |
| Fasting lipid profile | 1,2 | 1,2 | 1 | |
| Oral glucose tolerance test | 2 | 2 | ||
| Hand grip test | 1,2 | 1,2 | 1 | |
| 40-ft walk test | 1,2 | 1,2 | 1 | |
| Cognitive tests – EXIT, SLUMS, TAPS | 1,2 | 2 | 1 | |
| Cytokine profiles | 1,2 | 2 | 1,2 | 1 |
| Blood cell subsets by flow | 2 | 2 | 2 |
a
. RAPA/placebo treatment was initiated at week 0.
b
. “1” indicates a procedure performed for phase 1 of the study.
c
. “2” indicates a procedure performed for phase 2 of the study.
d
. randomization/blinding was handled by the Research Pharmacy with Graphpad QuickCalcs (https://www.graphpad.com/quickcalcs/randomize1/).
All other study participants and staff were blinded as to treatments until after completion of the project.