Table 3.
Summary of results in patients on placebo
| Measurements | Mean pre-placebo | Mean post-placebo | p value |
|---|---|---|---|
| Systolic BP (mmHg) | 135 ± 13 | 128 ± 17 | 0.19 |
| Diastolic BP (mmHg) | 82 ± 7 | 78 ± 11 | 0.27 |
| Total cholesterol (mmol/l) | 4.31 ± 0.85 | 4.50 ± 1.06 | 0.57 |
| HDL (mmol/l) | 1.05 ± 0.34 | 1.06 ± 0.35 | 0.96 |
| LDL (mmol/l) | 2.42 ± 0.70 | 2.50 ± 0.96 | 0.80 |
| Triglycerides (mmol/l) | 2.11 ± 1.15 | 2.39 ± 1.42 | 0.55 |
| HbA1c (mmol/mol) | 50 ± 15 | 51 ± 15 | 0.92 |
| Fructosamine (μmol/l) | 257 ± 53 | 266 ± 64 | 0.67 |
| HOMA-IR | 3.1 ± 1.8 | 3.0 ± 1.4 | 0.86 |
| ∆RI-GTN (%) | 24 ± 7 | 23 ± 6 | 0.58 |
| ∆RI-Salb (%) | 9 ± 6 | 9 ± 6 | 0.98 |
| sVCAM-1 (ng/ml) | 705 ± 423 | 722 ± 423 | 0.91 |
| cGMP (pmol/l) | 177 ± 46 | 177 ± 59 | 0.98 |
| Blood glutathione ratio | 20 ± 12 | 21 ± 9 | 0.65 |
| TAC (mM Asc [AEAC]) | 0.43 ± 0.06 | 0.44 ± 0.07 | 0.62 |
| hsCRP (mg/l) | 3.2 ± 5.3 | 2.7 ± 2.7 | 0.72 |
| ALT (iu/l) | 51 ± 19 | 49 ± 26 | 0.86 |
| AST (iu/l) | 40 ± 15 | 41 ± 17 | 0.90 |
| Mode ASQ (C2m) | 99 ± 10 | 95 ± 13 | 0.44 |
VSL#3® treated group n = 19; placebo treated group n = 16. Data expressed as mean and standard deviation. Four cGMP values were not measurable (3 from placebo group and 1 from VSL#3® group). HOMA-IR missing 1 value from each treatment group as insulin levels were outside the HOMA calculator range. HbA1c in the placebo group had one missing value. LDL cholesterol had missing data on 1 patient from placebo group and 1 from VSL#3® group as triglycerides were > 4.5 mmol/l which preclude LDL cholesterol calculation. SBP and DBP values were missing after intervention on 1 patient in the placebo group. Nineteen patients had completed ASQ (10 in VSL#3® group and 11 in placebo group). Missing data were excluded from respective analyses