Table 1
Schedule of data collection
| Before observation period | Start of administration | Dosing period | |||||
| Within 4 weeks | Day 0 | 2 weeks | 4 weeks | 8 weeks | 12 weeks | 24 weeks | |
|---|---|---|---|---|---|---|---|
| Allowance | Within ±1 week | Within ±1 week | Within ±2 weeks | Within ±2 weeks | Within ±4 weeks | ||
| Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 |
| Informed consent | X | ||||||
| Patient characteristics | X | ||||||
| Study drug administration |
| ||||||
| Symptom check |
| ||||||
| Adverse events check |
| ||||||
| Visceral fat area measured via CT | X | X | |||||
| Body weight | X | X | X | X | X | X | X |
| Heart rate, blood pressure | X | X | X | X | X | X | |
| Blood tests | X | X | X | X | X | ||
| Blood chemistry | X | X | X | X | X | ||
| Urine tests | X | X | X | X | X | X | |
| Insulin, bone marker, inflammation marker | X | X | X | ||||
| α1-Microglobulin | X | X | |||||
| Adipocytokine | X | X | |||||
| Waist circumference | X | X | X | X | X | X | X |
| Hand griping test | X | X | X | ||||
| Medication adherence check | X | X | X | X | X | ||
| Special examination* | X | X | |||||
| Screening blood examination | X | ||||||
*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.