TABLE 1.
Summary of study visits and procedures
| Procedure | Visit 1, screening | Visit 2, random assignment | Visit 3, telephone, 2 weeks | Visit 4, 4 to 6 weeks | Visit 5, telephone, 8 weeks | Visit 5, 12 weeks |
|---|---|---|---|---|---|---|
| Review of inclusion and exclusion criteria | X | X | – | – | – | – |
| Informed consent | X | – | – | – | – | – |
| Medical history | X | – | – | – | – | – |
| Review concomitant medications | X | X | X | X | X | X |
| Physical | X* | X† | – | X* | – | X† |
| Physician physical | X | – | – | – | – | X |
| Fasting blood work | X‡ | X§ | – | X¶ | – | X‡§ |
| Study drug dispensing | – | X | – | X | – | – |
| Study drug compliance | – | – | X | X | X | X |
| Review of adverse events | – | – | X | X | X | X |
Blood pressure and pulse measurements taken
Blood pressure, pulse, height, weight, and waist and hip circumference measurements taken
Total cholesterol, high-density lipoprotein cholesterol, low-density lipoprotein cholesterol, triglycerides, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine, urea, fasting plasma glucose, glycosylated hemoglobin, potassium, sodium, chloride, complete blood count and albumin to creatinine ratio measurements taken
Insulin, high-sensitivity C-reactive protein, vascular cell adhesion molecule-1, interleukin-6, tumour necrosis factor-alpha, plasminogen activator inhibitor type 1, matrix metalloproteinase-9, adiponectin and leptin measurements taken
Alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, creatinine, urea, fasting plasma glucose, potassium, sodium, chloride and complete blood count measurements taken. X Procedure will be performed