
Clinical Trial Schedule
Visit | Visit 1 (-week 2) Screening | Visit 2 (week 0) | Visit 3 (week 4) | Visit 4 (week 8) | Visit 5 (week 12) |
---|---|---|---|---|---|
Informed consent | ● | ||||
Demographic investigation | ● | ||||
Past history investigation | ● | ||||
Drug administration history | ● | ● | ● | ● | ● |
Vital signs | ● | ● | ● | ● | ● |
Electrocardiogram | ● | ● | |||
Height measurement | ● | ||||
Weight measurement | ● | ● | ● | ● | ● |
Waist circumstance measurement | ● | ● | ● | ● | ● |
Bioelectrical impedance analysis | ● | ● | ● | ● | ● |
Clinical laboratory examination/Pregnancy test | ● | ● | |||
Liver & Renal function test | ● | ● | |||
Lipid panel test | ● | ● | |||
Insulin test | ● | ● | |||
Immune function test | ● | ● | |||
Genetic test (serum) | ● | ||||
Inclusion/Exclusion criteria | ● | ||||
Random allocation | ● | ||||
Medication dispense | ● | ● | ● | ||
Stool sample acquisition | ● | ● | |||
Obesity pattern identification questionnaire | ● | ||||
Korean obesity-related quality of life questionnaire | ● | ● | |||
Food frequency questionnaire | ● | ● | ● | ● | |
3-day dietary recall | ● | ● | |||
Adverse events | ● | ● | ● | ● | |
Medication compliance assessment | ● | ● | ● |