Table 2. Changes in the Parameters of All Patients Between Baseline and Week 104 (n = 50).
| Interventional trial period |
P value (week 24 vs. baseline) | Post-trial monitoring period |
P value (week 104 vs. baseline) | |||
|---|---|---|---|---|---|---|
| Baseline | Week 24 | Week 52 | Week 104 | |||
| HbA1c (%) | 8.7 ± 1.5 | 7.7 ± 1.2 | < 0.001 | 7.7 ± 1.3 | 7.6 ± 1.2 | < 0.001 |
| Fasting plasma glucose (mg/dL) | 165.5 ± 40.5 | 137.6 ± 25.6 | < 0.001 | 148.1 ± 39.4 | 146.9 ± 34.7 | 0.020 |
| Body weight (kg) | 78.4 ± 19.7 | 75.8 ± 20.1 | < 0.001 | 76.0 ± 20.1 | 76.5 ± 20.6 | < 0.001 |
| UACR (mg/gCr) | 15.5 (8.0 - 95.7) | 12.9 (7.4 - 36.3) | 0.011† | 15.2 (8.0 - 39.0) | 14.0 (7.3 - 34.6) | 0.053† |
| eGFR (mL/min/1.73m2) | 82.1 ± 19.8 | 78.5 ± 17.4 | 0.007 | 82.2 ± 20.7 | 81.0 ± 20.2 | 0.526 |
| SBP (mm Hg) | 131.8 ± 13.1 | 130.1 ± 13.0 | 0.389 | 130.1 ± 14.9 | 130.5 ± 12.0 | 0.755 |
| DBP (mm Hg) | 80.7 ± 11.0 | 80.8 ± 10.5 | 0.888 | 80.9 ± 12.9 | 79.4 ± 10.9 | 0.411 |
| Fasting serum insulin (µU/mL) | 13.4 ± 6.3 | 13.2 ± 11.5 | 0.924 | 13.4 ± 11.7 | 12.9 ± 11.2 | 0.745 |
| HOMA-IR | 5.5 ± 3.4 | 4.7 ± 5.0 | 0.378 | 5.0 ± 5.0 | 4.7 ± 4.8 | 0.369 |
| HOMA-β (%) | 54.7 ± 35.3 | 67.0 ± 44.0 | 0.064 | 62.4 ± 45.4 | 61.1 ± 42.9 | 0.336 |
| Total cholesterol (mg/dL) | 180.8 ± 39.8 | 184.1 ± 39.8 | 0.274 | 178.4 ± 34.9 | 182.3 ± 33.3 | 0.720 |
| LDL-cholesterol (mg/dL) | 106.1 ± 32.2 | 109.3 ± 34.1 | 0.199 | 105.2 ± 30.1 | 107.7 ± 25.9 | 0.655 |
| HDL-cholesterol (mg/dL) | 48.3 ± 9.51 | 54.1 ± 10.4 | < 0.001 | 52.6 ± 9.5 | 53.5 ± 8.8 | < 0.001 |
| Triglycerides (mg/dL) | 157.1 ± 77.3 | 134.1 ± 71.7 | 0.028 | 149.1 ± 80.7 | 159.8 ± 98.3 | 0.849 |
| AST (IU/L) | 39.4 ± 16.7 | 26.0 ± 8.6 | < 0.001 | 28.2 ± 11.8 | 33.1 ± 19.7 | 0.044 |
| ALT (IU/L) | 56.2 ± 29.7 | 35.6 ± 19.5 | < 0.001 | 38.8 ± 21.0 | 44.6 ± 33.4 | 0.003 |
| γ-GT (IU/L) | 62.3 ± 55.6 | 41.0 ± 34.5 | < 0.001 | 45.1 ± 57.5 | 54.0 ± 84.0 | 0.396 |
| Uric acid (mg/dL) | 5.5 ± 1.3 | 4.7 ± 1.1 | < 0.001 | 4.9 ± 1.2 | 4.9 ± 1.3 | < 0.001 |
| Serum creatinine (mg/dL) | 0.68 ± 0.16 | 0.71 ± 0.16 | 0.011 | 0.68 ± 0.16 | 0.68 ± 0.17 | 0.721 |
| Hematocrit (%) | 42.6 ± 4.1 | 45.4 ± 4.5 | < 0.001 | 44.8 ± 4.8 | 45.5 ± 4.3 | < 0.001 |
Data are means ± standard deviation (SD) or medians with the interquartile range (IQR). P value versus baseline by the paired t-test. †P value versus baseline by the Wilcoxon signed-rank test. HbA1c: glycated hemoglobin; UACR: urinary albumin-to-creatinine ratio; eGFR: estimated glomerular filtration rate; SBP: systolic blood pressure; DBP: diastolic blood pressure; HOMA-IR: homeostasis model assessment of insulin resistance; HOMA-β: homeostasis model assessment of β-cell function; LDL-cholesterol: low-density lipoprotein cholesterol; HDL-cholesterol: high-density lipoprotein cholesterol; AST: aspartate aminotransferase; ALT: alanine aminotransferase; γ-GT: γ- glutamyltransferase.