Remission effect of Canagliflozin in patients with newly diagnosed type 2 diabetes mellitus: a protocol for a multicenter, parallel-group, randomized, controlled, open-label trial

Table 1 Participant visit schedule

Research Stage	Screening	Baseline	Intervention Period				Follow-up Period
Research Stage	Screening	Baseline	Start of treatment	Dose titration period (weekly)	Maintenance treatment (monthly)	Drug discontinuance	First three months (monthly)	Last nine months (every three months)	End of the follow-up
Informed consent		×	×	×	×	×	×	×	×
Participant information		×	×	×	×	×	×	×	×
Medical history		×	×	×	×	×	×	×
Clinical examination		×	×	×	×	×	×	×
Inclusion and exclusion criteria		×	×	×	×	×	×	×	×
Assignment filter number		×	×	×	×	×	×	×	×
Weight, height, and BMI
Body composition	×		×	×	×		×	×
Waist circumference
Blood pressure and resting heart rate
HbA1c, FPG, 2hPG			×	×	×		×
FCP, 2hCP, FINS, INS-2 h	×		×	×	×		×
Blood biochemistry, blood routine			×	×	×		×
Thyroid function		×	×	×	×	×	×	×	×
Routine urine, urine microalbumin			×	×	×		×
ECG, UCG		×	×	×	×	×	×	×	×
Abdominal ultrasonography	×		×	×	×	×	×	×
Eye-ground photography, electromyography, color doppler ultrasound of blood vessels of the neck and lower limbs	×		×	×	×	×	×	×
Stored samples (blood and stool)	×		×	×	×		×	×
DSQLS、SDSCA	×		×	×	×		×	×
Medication, diet, and exercise guidance	×
Treatment of comorbidity	×
Blood glucose monitoring	×	×
Dietary and sport record	×	×
Occurrence of hypoglycemia, ketosis, and other adverse reactions	×	×
Distribute participant diaries		×	×	×	×	×	×	×
Recall and review participant diaries	×	×	×	×	×	×	×	×

BMI, body mass index; ECG, electrocardiograph; FCP, fasting C-peptide; FINS, fasting serum insulin; HbA1c, glycosylated hemoglobin A1c; 2hCP, 2 - hour postprandial C-peptide; INS-2 h, 2 - hour postprandial insulin; DSQLS, diabetes specific quality of life scale; SDSCA, summary of diabetes self care activities; UCG, ultrasonic cardiogram

ISSN: 1472-6823