Table 3.
Selected secondary endpoints
| Liner | Balloon | Sham | |||
|---|---|---|---|---|---|
| estimate | estimate | difference to liner (95% CI) | estimate | difference to liner (95% CI) | |
| HbA1c, % | Negative differences indicate superiority | ||||
| Baseline | 7.03 | 6.35 | 6.62 | ||
| 6 months | 6.57 | 6.26 | 0.37 (0.06 to 0.68) | 6.54 | 0.38 (−0.00 to 0.77) |
| 12 months | 6.62 | 6.29 | 0.36 (−0.01 to 0.72) | 6.56 | 0.35 (−0.06 to 0.77) |
| 24 months | 6.81 | 6.46 | 0.33 (−0.05 to 0.72) | 6.76 | 0.36 (−0.06 to 0.78) |
| Physical functioning (SF-36) | Positive differences indicate superiority | ||||
| Baseline | 58 | 55 | 60 | ||
| 1 month | 64 | 74 | 13 (2 to 23) | 71 | 5 (−7 to 17) |
| 3 months | 65 | 71 | 9 (−2 to 19) | 72 | 5 (−6 to 17) |
| 6 months | 69 | 72 | 5 (−6 to 16) | 73 | 2 (−11 to 15) |
| 12 months | 72 | 68 | −1 (−13 to 10) | 69 | −5 (−18 to 8) |
| 18 months | 68 | 74 | 8 (−4 to 20) | 73 | 2 (−11 to 16) |
| 24 months | 66 | 69 | 6 (−6 to 18) | 84 | 16 (2 to 29) |
| Physical activity (IPAQ), MET-h/day | Positive differences indicate superiority | ||||
| Baseline | 6.1 | 5.8 | 5.3 | ||
| 6 months | 7.8 | 8.6 | 1.1 (−3.6 to 5.8) | 5.4 | −1.7 (−4.4 to 4.2) |
| 12 months | 9.5 | 7.3 | −1.9 (−7.3 to 3.3) | 9.0 | 0.2 (−6.1 to 6.5) |
| 24 months | 7.8 | 4.9 | −2.6 (−8.3 to 3.1) | 5.7 | −1.4 (−7.8 to 5.0) |
| Percentage fat according to BIA | Negative differences indicate superiority | ||||
| Baseline | 36.3 | 35.1 | 40.1 | ||
| 6 months | 34.1 | 30.4 | −2.5 (−5.8 to 0.7) | 37.0 | −1.0 (−4.7 to 2.8) |
| 12 months | 32.6 | 31.7 | 0.3 (−3.3 to 3.7) | 39.2 | 2.7 (−1.1 to 6.6) |
| 24 months | 36.1 | 35.0 | 0.1 (−3.6 to 3.8) | 40.4 | 0.4 (−3.7 to 4.5) |
Bold lettering indicates that the 95% CI does not contain the value zero.
BIA, bioelectrical impedance analysis; HbA1c, glycated hemoglobin; IPAQ, International Physical Activity Questionnaire; MET, metabolic equivalent of task; SF-36, Short Form (36) Health Survey.