Table 1 Measurement items and point of data capture
Visit project | Screening period/baseline | Visit 1 | Visit 2 | Visit 3 | Visit 4-6 | |
|---|---|---|---|---|---|---|
Visiting time | –7 to 0 days | Medication week 4 | Medication week 8 | Medication week 12 | Follow-up weeks 4, 8, and 12 | |
Collect basic medical history | ||||||
Sign informed consent | √ | |||||
Fill in general information | √ | |||||
Medical history and treatment history | √ | |||||
Determine inclusion and exclusion criteria | √ | |||||
Physical examination | √ | √ | √ | √ | √ | |
Comorbidity and medication records | √ | √ | √ | √ | √ | |
Effectiveness observation | ||||||
Glycosylated hemoglobin | √ | √ | √ | |||
Fasting blood glucose | √ | √ | √ | |||
Postprandial blood glucose | √ | √ | √ | |||
Fasting insulin | √ | √ | ||||
Fasting C-peptide | √ | √ | ||||
Inflammatory factors | √ | √ | ||||
Other work | ||||||
Random grouping | √ | |||||
Fecal specimen | √ | √ | √ | |||
Liver and kidney function | √ | √ | √ | |||
Adverse event | √ | √ | √ | √ | √ | |