Table 3.
Changes in secondary outcomes during the study. Values are mean and standard errors estimated by a linear model for repeated measures (cluster confidence intervals)
| Placebo
|
VSL#3
|
P-value* | |||
|---|---|---|---|---|---|
| Baseline | 4 months | Baseline | 4 months | ||
| Triglycerides (mg/dL) | 98 (3) | 102 (10) | 99 (4) | 110 (9) | 0.575 |
|
| |||||
| HOMA | 4.7 (0.4) | 3.5 (0.6) | 4.3 (0.3) | 3.3 (0.3) | 0.693 |
|
| |||||
| ALT (U/L) | 42 (1) | 50 (5) | 34 (1) | 33 (1) | 0.170 |
|
| |||||
| BMI (kg/m2) | 25.6 (0.01) | 25.7 (0.24) | 27.1 (0.01) | 24.9 (0.2) | <0.001 |
|
| |||||
| BMI (SDS) | 1.68 (0.01) | 1.68 (0.04) | 1.94 (0.01) | 1.58 (0.04) | <0.001 |
|
| |||||
| GLP-1 (pmol/L) | 2.25 (0.03) | 2.17 (0.11) | 2.20 (0.02) | 3.24 (0.19) | <0.001 |
|
| |||||
| a-GLP1 (pmol/L) | 1.44 (0.01) | 1.42 (0.13) | 1.58 (0.02) | 2.20 (0.05) | <0.001 |
*
Tests whether there is a change in time of the outcomes of interest for the VSL#3 vs. placebo group taking into account baseline values of the outcome (Wald test for treatmentXtime interaction, linear model for repeated measures).