Study timeline and investigations
| Baseline | Week 1 | Week 6 | 3 months | 6 months | 9 months | 12 months | 18 months | 2 years | 3 years | 4 years | 5 years | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Clinical history and medications | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Blood pressure | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Anthropometrics | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| DEXA/REE* | ✓ | ✓ | ✓ | |||||||||
| Endocrinology review | ✓ | ✓ | ✓ | 21 months | 33 months | 45 months | 57 months | |||||
| Hospital anxiety and depression score | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Short form health survey instrument (SF-36) | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | |
| Laboratory tests† | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| HbA1c | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ||
| Stored fasting plasma and serum | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ | ✓ |
| Mechanistic substudy | ||||||||||||
| Food diary | ✓ | ✓ | ✓ | |||||||||
| Satiety questionnaire | ✓ | ✓ | ✓ | |||||||||
| Fecal sample‡ | ✓ | ✓ | ✓ | |||||||||
| Plasma and serum samples from oral glucose tolerance test§ | ✓ | ✓ | ✓ | |||||||||
*Dual-energy X-ray absorptiometry/resting energy expenditure.
†Full blood count, C reactive protein, ESR, electrolytes, creatinine, calcium, albumin, bilirubin, liver enzymes, lipids and 25-hydroxy-vitamin D.
‡Samples immediately frozen.
§Samples also stored in BD P800 tubes for gut hormone analysis.