Table 2.
Summary of study visit schedule
| Activities | Screening | Baseline | Treatment | Follow-up | |||||||||||||||||||
| V1 | V2 | V3 | V4 | T1 | V5 | V6 | T2 | V7 | T3 | V8 | T4 | V9 | T5 | V10 | V11 | T6 | V12 | T7 | V13 | T8 | V14 | V15 | |
| Week/month/day | −4w ±7d |
−2w ±7d |
−0w ±3d |
+5d ±3d |
+10d ±3 |
+1m ±7d |
+2m ±7d |
+3m ±7d |
+4.5m ±7d |
+6m ±7d |
+7.5m ±7d |
+9m ±7d |
+10.5m ±7d |
+11.5m ±7d |
+12m ±7d |
+13.5m ±7d |
+15m ±7d |
+16.5m ±7d |
+18m ±7d |
+19.5m ±7d |
+23m ±7d |
+24m ±7d |
|
| Informed consent | X | ||||||||||||||||||||||
| Inclusion and exclusion criteria | X | ||||||||||||||||||||||
| Demographics | X | ||||||||||||||||||||||
| Medical history (including meds) | X | ||||||||||||||||||||||
| Physical examination | X | ||||||||||||||||||||||
| ECG | X | ||||||||||||||||||||||
| Vital signs | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||
| Body weight | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||
| Height | X | ||||||||||||||||||||||
| Waist circumference | X | X | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||
| Routine blood tests | X | X | X | X | X | X | X | X | X | X | X | X | X | ||||||||||
| Urine dipstick and female pregnancy test | X | ||||||||||||||||||||||
| Changes in medical history/medication | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
| Randomisation | X | ||||||||||||||||||||||
| Health economic questionnaires | X | X | X | X | X | X | X | ||||||||||||||||
| Dietary counselling | X | C | |||||||||||||||||||||
| Dietitian follow-up | X | X | X | X | X | X | X | ||||||||||||||||
| Urine albumin:creatinine ratio | X | X | X | X | X | ||||||||||||||||||
| Reporting of AEs | X | X | X | X | X | X | X | X | X | X | X | X | X | X | |||||||||
| DNA and RNA sampling | X | X | X | X | X | ||||||||||||||||||
| Telephone counselling | X | X | X | X | X | X | X | X | |||||||||||||||
| Diabetologist review | X | C | X | X | X | C | X | X | X | ||||||||||||||
| Metabolomics | X | X | X | X | X | ||||||||||||||||||
| Bioelectrical impedance | X | X | X | X | X | ||||||||||||||||||
| EndoBarrier group only | |||||||||||||||||||||||
| PPI and Helicobacter pylori test | X | ||||||||||||||||||||||
| Distribution of proton pump inhibitors | T | ||||||||||||||||||||||
| EndoBarrier implant | T | ||||||||||||||||||||||
| Preparation for EndoBarrier removal | T | ||||||||||||||||||||||
| EndoBarrier removal | T | ||||||||||||||||||||||
| Biopsies during implant and explant | T | T | |||||||||||||||||||||
| Gastroenterologist appointment | T | T | T | T | T | T | T* | T | |||||||||||||||
| Subgroups | |||||||||||||||||||||||
| Fixed/test meal and postmeal gut hormones and metabolites (groups 1 and 3) |
X | X | X | X | |||||||||||||||||||
| Gut hormones and metabolites (fasting only) (groups 1–3) | X | X | X | X | X | ||||||||||||||||||
| Food diaries (groups 1–3) | X | X | X | X | X | ||||||||||||||||||
| Eating and behaviour questionnaires (groups 1–3) | X | X | X | X | |||||||||||||||||||
| Appetite Visual Analogue Scales (groups 1–3) | X | X | X | X | X | ||||||||||||||||||
| Eating behaviour computerised tasks (groups 1 and 3) | X | X | X | X | |||||||||||||||||||
| Metal check form (group 1) | X | ||||||||||||||||||||||
| Handedness questionnaire (group 1) | X | ||||||||||||||||||||||
| Additional pregnancy tests | F | F | |||||||||||||||||||||
| DS-R disgust questionnaire (group 1) | X | ||||||||||||||||||||||
| Functional MRI (group 1) |
X | X | |||||||||||||||||||||
| Insulin clamps (group 2) | X | X | X | ||||||||||||||||||||
| Cognitive assessment tasks (group 1) | X | X | X | X | |||||||||||||||||||
| Food preference/taste assessment (group 3) | X | X | X | ||||||||||||||||||||
| 24-Hour dietary recall (group 3) | X | X | X | X | X | ||||||||||||||||||
*Optional (at request of the patient).
X, performed in all patients unless otherwise stated; F, performed in females only; C, performed in control arm (standard medical therapy) only; T, performed in treatment arm (EndoBarrier) only.
PPI, proton pump inhibitor; AE, adverse event; DS-R, disgust scale-revised.