Table 1

Schedule of data collection

Before observation periodStart of administrationDosing period
Within 4 weeksDay 02 weeks4 weeks8 weeks12 weeks24 weeks
AllowanceWithin ±1 weekWithin ±1 weekWithin ±2 weeksWithin ±2 weeksWithin ±4 weeks
Visit1234567
Informed consentX
Patient characteristicsX
Study drug administration Embedded Image
Symptom check Embedded Image
Adverse events check Embedded Image
Visceral fat area measured via CTXX
Body weightXXXXXXX
Heart rate, blood pressureXXXXXX
Blood testsXXXXX
Blood chemistryXXXXX
Urine testsXXXXXX
Insulin, bone marker, inflammation markerXXX
α1-MicroglobulinXX
AdipocytokineXX
Waist circumferenceXXXXXXX
Hand griping testXXX
Medication adherence checkXXXXX
Special examination*XX
Screening blood examinationX
  • *Special examination includes whole-body DXA, dietary behaviour questionnaire, respiratory quotient, basal metabolism, and calorie and glucose intake for patients.

  • DXA, dual-energy X-ray absorption.