Table 7.
Estimate (β), Standard Error, and p-value of the treatment effect on the primary and secondary endpoints, evaluated as difference between pre- and post-treatment, using a linear mixed model.
| Endpoints | Time × Group β [95%CI] |
p-Value Unadjusted |
p-Value Adjusted |
|---|---|---|---|
| Primary endpoint | |||
| HOMA | −0.69 [−1.06; −0.31] | 0.0009 | 0.003 |
| Secondary endpoints | |||
| Total Cholesterol (mg/dL) | −5.00 [−18.21; 8.21] | 0.42 | 0.49 |
| HDL (mg/dL) | 2.58 [−3.18; 8.35] | 0.34 | 0.45 |
| LDL (mg/dL) | −3.45 [−12.54; 5.64] | 0.42 | 0.49 |
| VLDL (mg/dL) | −3.11 [−5.55; −0.66] | 0.02 | 0.03 |
| CRP(mg/dL) | −0.14 [−0.23; −0.04] | 0.008 | 0.02 |
| TNF α (pg/mL) | −6.17 [−9.91; −2.44] | 0.004 | 0.009 |
| Triglycerides (mg/dL) | −15.42 [−27.65; −3.18] | 0.02 | 0.03 |
| Glycemia (mg/dL) | −4.50 [−6.20; −2.80] | <0.0001 | 0.0001 |
| Insulin (mcU/mL) | −2.83 [−4.51; −1.15] | 0.002 | 0.005 |
| SHBG (nmol/L) | 9.04 [2.07; 16.01] | 0.02 | 0.03 |
| CPK (U/L) | −29.00 [−50.58; −7.42] | 0.01 | 0.02 |
| Free Testosterone (ng/mL) | −0.15 [−0.24; −0.06] | 0.003 | 0.007 |
| FAI | −0.78 [−2.04; 0.47] | 0.20 | 0.28 |
| Total Bilirubin (mg/dL) | −0.01 [−0.13; 0.12] | 0.91 | 0.91 |
| AST (IU/L) | −2.00 [−7.85; 3.85] | 0.47 | 0.52 |
| ALT (IU/L) | −2.67 [−8.86; 3.52] | 0.36 | 0.45 |
| GGT (U/L) | −0.17 [−1.62; 1.29] | 0.81 | 0.84 |
| BMI (kg/m2) | −0.41 [−0.64; −0.19] | 0.001 | 0.003 |
| Waist Circumference (cm) | −1.42 [−2.27; −0.57] | 0.002 | 0.005 |
| Hip Circumference (cm) | −0.96 [−1.49; −0.42] | 0.001 | 0.003 |
| W/H ratio (pt) | −0.006 [−0.01; −0.0004] | 0.03 | 0.04 |
| VAT (g) | −49.96 [−75.85; −24.06] | 0.0006 | 0.003 |
| Total Mass (kg) | −1.17 [−1.73; −0.61] | 0.0003 | 0.002 |
| Fat Mass (g) | −857.25 [−1334.43; −380.06] | 0.001 | 0.003 |
| Lean Mass (g) | −306.75 [−661.89; 48.39] | 0.09 | 0.13 |
| GAGS (pt) | −8.17 [−9.28; −7.05] | <0.0001 | <0.0001 |
| CADI (pt) | −8.58 [−9.65; −7.52] | <0.0001 | <0.0001 |