Table 3.
Screen- ing |
Base- line |
Week 2,4,6, 8,10,12 |
Month | Q 4M |
Q 12M |
EXIT | |||
---|---|---|---|---|---|---|---|---|---|
4 | 8 | 12 | |||||||
Physical examination1 | X | X | X | X | |||||
Medical history | X | X | |||||||
Blood test | |||||||||
Hemoglobin | X | ||||||||
HbA1c | X | ||||||||
Alanine transaminase | X | X | X | X | |||||
Fasting glucose | X | X | X | X | |||||
Fasting lipid profile | X | X | X | ||||||
Fasting insulin | X | X | |||||||
HS C-reactive protein | X | X | |||||||
NIH Stroke Scale | X | ||||||||
Medication inventory | X | X | X | X | |||||
Modified Mini-mental Exam | X | X | X | X | |||||
Lifestyle survey3 | X | X | X | X | |||||
Safety and outcome screening 4 | X | X | X | X | X | X | X | ||
Study medication dose changes | 4 and 8 weeks | ||||||||
Study medication resupply | 12 weeks | X | X | X | X | X |
Blood pressure, weight, height, edema grade, waist and hip measurements.
Tobacco use, alcohol use, exercise habits.
Self-reported weight, edema symptoms, shortness of breath, muscle aches, macroscopic hematuria; new diagnoses of stroke, MI, diabetes, CHF, cancer, fracture, macular edema; all hospitalizations.