Blood samples planned during the enrolment and control visits
| Visit 1 | Visit 2 | Visit 3 | Visit 4 | Visit 5 | Visit 6 | Visit 7 | |
|---|---|---|---|---|---|---|---|
| Screening visit | Baseline visit | Follow-up visit (+1 month) | Follow-up visit (+3 months) | Follow-up visit (+6 months) | Follow-up visit (+9 months) | Follow-up visit (+12 months) | |
| Glucose disposal and insulin secretion | |||||||
| Fasting plasma glucose | x | x | x | x | x | x | x |
| Fasting insulin and C-peptide | x | x | x | x | x | x | x |
| HbA1c | x | x | x | ||||
| 3-h OGTT | x | x | x | x | x | x | |
| Special | |||||||
| Total cholesterol | x | x | x | x | x | ||
| HDL-cholesterol | x | x | x | x | x | ||
| Triglycerides | x | x | x | x | x | ||
| Safety | x | x | |||||
| Haematology profile | x | x | x | x | x | x | |
| Chemistry panel | x | x | x | x | x | x | x |
| Serum pregnancy test* | x | ||||||
| Total blood samples (ml) | 80 | 80 | 80 | 80 | 800 | 800 | 80 |
*In female patients of childbearing potential before operation.
HbA1c, glycated haemoglobin; HDL, high-density lipoprotein; OGTT, oral glucose tolerance test.