Changes in anthropometric parameters and biomarkers after treatment
| Initial triple therapy (n=86) | Conventional stepwise therapy (n=84) | P value* | |||||
| Baseline | 12 months | P value | Baseline | 12 months | P value | ||
| Body mass index (kg/m2) | 25.9±4.9 | 26.7±4.8 | <0.01 | 25.6±3.6 | 26.4±3.7 | <0.01 | NS |
| SBP (mm Hg) | 131.0±17.6 | 131.3±16.7 | NS | 132.0±15.8 | 135.2±17.0 | NS | NS |
| DBP (mm Hg) | 79.9±12.8 | 78.1±10.8 | NS | 79.7±11.2 | 79.7±11.7 | NS | NS |
| HbA1c (%) | 10.7±1.0 | 6.7±1.3 | <0.01 | 10.5±1.0 | 7.3±1.2 | <0.01 | <0.05 |
| Fasting plasma glucose (mg/dL) | 228.3±60.1 | 128.1±35.6 | <0.01 | 221.1±67.8 | 140.8±36.2 | <0.01 | <0.05 |
| Postload 30 min glucose (mg/dL) | 318.3±69.2 | 185.9±49.8 | <0.01 | 314.1±67.6 | 238.1±28.9 | 0.068 | <0.05 |
| Postload 120 min glucose (mg/dL) | 366.5±84.9 | 185.8±71.3 | <0.01 | 352.3±85.2 | 238.6±70.5 | <0.01 | <0.05 |
| AUCglucose | 308.9±64.5 | 165.2±40.2 | <0.01 | 309.3±58.2 | 237.3±43.9 | <0.01 | <0.05 |
| Fasting plasma insulin (μIU/mL) | 10.8±6.1 | 9.4±5.0 | NS | 10.4±5.5 | 10.9±5.1 | NS | NS |
| Postload 30 min insulin (μIU/mL) | 15.7±9.0 | 25.4±12.6 | <0.01 | 15.6±7.4 | 12.6±3.3 | NS | <0.05 |
| Postload 120 min insulin (μIU/mL) | 20.7±20.1 | 46.3±47.4 | <0.01 | 19.8±17.1 | 16.8±5.8 | NS | <0.05 |
| AUCinsulin | 15.8±9.7 | 26.7±17.9 | <0.01 | 14.8±7.9 | 12.9±3.5 | NS | <0.05 |
| C-peptide (ng/mL) | 2.2±1.3 | 2.5±1.0 | NS | 2.6±1.4 | 3.1±1.6 | NS | NS |
| HOMA-IR† | 6.1±3.7 | 2.7±1.5 | <0.01 | 5.7±3.4 | 4.5±2.4 | NS | <0.05 |
| HOMA-β† | 27.2±18.7 | 81.1±66.1 | <0.01 | 31.1±28.8 | 43.1±26.5 | NS | <0.05 |
| QUICKI | 0.50±0.07 | 0.59±0.07 | <0.01 | 0.50±0.08 | 0.52±0.07 | 0.029 | <0.05 |
| Matsuda index | 4.35±2.55 | 6.56±3.34 | <0.01 | 4.91±3.03 | 6.01±3.45 | <0.01 | <0.05 |
| IGI30 | 0.044±0.089 | 0.298±0.263 | <0.01 | 0.064±0.069 | 0.050±0.063 | NS | <0.05 |
| IGI120 | 0.154±0.583 | 0.481±1.893 | <0.01 | 0.149±0.403 | 0.070±0.053 | NS | <0.05 |
| Disposition index | 0.20±0.32 | 1.96±2.55 | <0.01 | 0.31±0.39 | 0.25±0.29 | NS | <0.05 |
| Glucagon (pg/mL) | 194.0±76.0 | 180.3±76.3 | NS | 206.6±90.9 | 210.5±106.1 | NS | NS |
| Total cholesterol (mg/dL) | 207.9±43.3 | 178.1±38.3 | <0.01 | 206.5±52.8 | 172.6±40.5 | <0.01 | NS |
| Triglycerides (mg/dL) | 184.9±130.3 | 144.1±81.3 | <0.01 | 192.0±179.7 | 171.4±117.4 | NS | <0.05 |
| HDL-cholesterol (mg/dL) | 46.9±9.4 | 49.1±8.9 | <0.05 | 50.0±12.1 | 47.1±9.8 | NS | <0.05 |
| LDL-cholesterol (mg/dL) | 125.3±33.4 | 100.5±30.5 | <0.01 | 125.1±38.5 | 96.7±30.3 | <0.01 | NS |
| Free fatty acid (μmol/L) | 590.7±208.2 | 396.3±150.7 | NS | 684.6±191.4 | 571.5±206.3 | NS | NS |
| AST (IU/L) | 26.5±13.2 | 27.8±22.1 | NS | 28.1±15.5 | 33.4±21.9 | <0.05 | <0.05 |
| ALT (IU/L) | 34.3±29.1 | 30.3±29.5 | NS | 35.9±29.0 | 41.6±33.6 | NS | <0.05 |
| Serum creatinine (mg/dL) | 0.76±0.19 | 0.79±0.20 | NS | 0.77±0.19 | 0.81±0.29 | NS | NS |
| Urinary albumin-creatinine ratio (mg/g) | 87.4±243.7 | 72.8±278.8 | <0.05 | 108.6±305.6 | 114.9±388.2 | NS | <0.05 |
Data are expressed as mean±SD. P values were calculated using a paired t-test between the values recorded at the baseline and after treatment.
*P values were calculated using Student’s t-test for delta changes between the two groups.
†Log-transformed values were used for comparison.
ALT, alanine aminotransferase; AST, aspartate aminotransferase; AUC, area under the curve; DBP, diastolic blood pressure; HDL, high-density lipoprotein; HOMA-β, homeostasis model assessment of β-cell function; HOMA-IR, homeostasis model assessment of insulin resistance; IGI, insulinogenic index; LDL, low-density lipoprotein; NS, not significant; QUICKI, quantitative insulin sensitivity check index; SBP, systolic blood pressure.