Table 3.
Changes in insulin sensitivity, inflammatory, and safety markers after 12-week treatment by intention-to-treat analysis.
| Anthocyanins (n = 80) | Placebo (n = 80) | Net Change (95% CI) | Pt-test | PANCOVA | |||||
|---|---|---|---|---|---|---|---|---|---|
| Baseline | 12 Weeks | Change | Baseline | 12 Weeks | Change | ||||
| Markers of Insulin sensitivity | |||||||||
| HOMA-IR | 3.18 ± 1.95 | 3.12 ± 1.94 | −0.06 ± 1.76 | 3.30 ± 1.75 | 3.35 ± 2.09 | 0.05 ± 1.23 | −0.11 (−0.59 ± 0.36) | 0.636 | 0.568 |
| HOMA-β | 94.87 ± 56.35 | 84.45 ± 45.64 | −10.41 ± 44.86 * | 97.54 ± 77.53 | 89.03 ± 52.53 | −8.51 ± 54.22 | −1.91 (−17.45 ± 13.63) | 0.809 | 0.563 |
| AUCGlucose | 28.82 ± 6.42 | 30.47 ± 5.99 | 1.65 ± 5.39 * | 29.11 ± 6.35 | 29.11 ± 6.35 | 1.68 ± 4.69 * | −0.02 (−1.60 ± 1.56) | 0.977 | 0.412 |
| AUCInsulin | 206.66 ± 99.75 | 235.41 ± 134.69 | 28.76 ± 119.08 * | 227.34 ± 108.68 | 255.48 ± 146.38 | 28.14 ± 87.83 * | 0.61 (−32.06 ± 33.29) | 0.970 | 0.971 |
| AUCC-Peptide | 26.32 ± 6.51 | 27.05 ± 7.06 | 0.74 ± 5.60 | 27.14 ± 6.87 | 28.30 ± 8.20 | 1.16 ± 5.15 * | −0.42 (−2.10 ± 1.26) | 0.619 | 0.524 |
| Insulinogenic index | 10.94 ± 8.96 | 11.28 ± 8.99 | 0.34 ± 6.21 | 12.90 ± 8.68 | 13.19 ± 9.18 | 0.30 ± 5.95 | 0.04 (−1.86 ± 1.94) | 0.964 | 0.636 |
| Insulin clearance | 7.09 ± 2.04 | 6.47 ± 2.12 | −0.61 ± 1.58 * | 6.49 ± 1.61 | 6.15 ± 1.70 | −0.34 ± 1.15 * | −0.27 (−0.70 ± 0.16) | 0.216 | 0.625 |
| Inflammatory markers | |||||||||
| CRP (mg/L) | 1.90 ± 1.97 | 2.24 ± 2.70 | 0.34 ± 2.05 | 2.20 ± 2.87 | 2.65 ± 3.72 | 0.45 ± 3.93 | −0.11 (−1.09 ± 0.87) | 0.821 | 0.522 |
| Uric Acid (umol/L) | 390.4 ± 111.1 | 365.1 ± 115.8 | −25.3 ± 98.3 * | 352.3 ± 92.8 | 337.3 ± 103.0 | −15.0 ± 58.9 * | −10.2 (−35.5 ± 15.1) | 0.426 | 0.646 |
| Markers on liver and renal function | |||||||||
| ALT (U/L) | 21.58 ± 8.66 | 20.40 ± 9.30 | −1.18 ± 7.40 | 23.63 ± 8.78 | 21.01 ± 9.20 | −2.62 ± 5.11 * | 1.45 (−0.54, 3.43) | 0.153 | 0.387 |
| AST (U/L) | 22.05 ± 5.68 | 23.20 ± 6.15 | 1.15 ± 5.08 * | 22.78 ± 5.36 | 22.71 ± 5.66 | −0.07 ± 3.69 | 1.22 (−0.17, 2.60) | 0.085 | 0.150 |
| Creatinine (umol/L) | 74.47 ± 20.40 | 74.60 ± 20.64 | 0.13 ± 7.92 | 71.56 ± 20.21 | 72.71 ± 22.17 | 1.15 ± 8.05 | −1.02 (−3.51,1.48) | 0.421 | 0.550 |
Data are presented as mean ± standard deviation. * p < 0.05 by paired t-test with comparison of the difference between baseline and 12-week data. HOMA-IR: homoeostasis model assessment of insulin resistance; HOMA-IR = FIns(mU/mL) × FG(mmol/L)/22.5. FIns: Fasting insulin; FG: fasting glucose; HOMA-β: homoeostasis model assessment of β-cell function; HOMA-β = FIns × 20/(FG-3.5). AUC, area under the curve by 3-h oral glucose tolerance test, were calculated according the trapezoidal rule. CRP: C-reactive protein. Insulinogenic index = (Insulin30min-Insulin0min)/(Glucose30min-Glucose0min). Insulin clearance = AUCC-Peptide/AUCInsulin (Insulin 1 μU/mL * 6.945 = 1 pmol/L, C-Peptide 1 ng/mL * 333.33 = 1 pmol/L). ALT: alanine transaminase; AST: aspartate transaminase.