Table 1.
Patient visit schedule
| Time (accepted variation) |
Screening | Baseline | Operation 0 |
Follow-up period | |||||
| −3 weeks (−52 to −2) |
5 weeks (4–8) |
16 weeks (12–24) |
34 weeks (28–40) |
52 weeks (46–60) |
2, 3 and 4 years±2 months |
5 years±4 months |
|||
| Visit | 1 | 2 | 3 | 4 | 5 | 6 | 7 | 8–10 | 11 |
| Demographic data | x | ||||||||
| Comorbidities | x | ||||||||
| Regular medication | x | x | x | x | x | x | x | ||
| Clinical examination | x | x | x | x | x | x | x | x | |
| Physician consultation | x | x | x | x | x | x | x | x | |
| Inclusion and exclusion criteria | x | ||||||||
| Signed informed consent | x | ||||||||
| Blood samples* | x | x | x | x | x | x | x | x | x |
| Urine samples* | x | x | x | x | |||||
| Faecal sample* | x | x | x | x | |||||
| Pulse wave velocity | x | x | x | x | |||||
| Bioelectrical impedance analysis | x | x | x | x | x | x | x | ||
| ECG | x | x | x | ||||||
| OGTT and FSIGT | x | x | x | x | |||||
| PROMs questionnaires (web) | x | x | x | x | x | ||||
| Food frequency questionnaire | x | x | x | ||||||
| DEXA | x | x | x | ||||||
| MRI | x | x | x | x | |||||
| Upper endoscopy | x | x | x | ||||||
| Manometry | x | x | x | ||||||
| pH measurement | x | x | x | ||||||
| Twenty-four hours ambulatory blood pressure | x | x | x | x | |||||
| SenseWear | x | x | x | x | |||||
| ApneaLink | x | x | x | x | |||||
| Hypoglycaemia/dumping | x | x | x | x | x | x | x | ||
| Adverse events | x | x | x | x | x | x | x | ||
*See table 2.
DEXA, dual-energy X-ray absorptiometry; FSIGT, frequently sampled glucose tolerance test; OGTT, oral glucose tolerance test; PROMs, patient-reported outcome measures.