Table 3. Changes in the Parameters of Patients With Diabetic Nephropathy Between Baseline and Week 104 (n = 16).
| 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 (%) | 9.0 ± 1.8 | 8.0 ± 1.2 | 0.013 | 7.7 ± 1.4 | 7.7 ± 1.0 | 0.006 |
| Fasting plasma glucose (mg/dL) | 162.5 ± 32.1 | 135.9 ± 20.2 | 0.028 | 141.9 ± 32.5 | 138.5 ± 26.0 | 0.033 |
| Body weight (kg) | 82.9 ± 15.7 | 80.2 ± 15.9 | < 0.001 | 80.5 ± 15.5 | 82.1 ± 18.2 | < 0.001 |
| UACR (mg/gCr) | 119.2 (98.9 - 201.8) | 52.9 (24.8 - 242.1) | 0.049† | 81.8 (24.3 - 174.3) | 36.9 (19.7 - 204.7) | 0.011† |
| eGFR (mL/min/1.73m2) | 77.9 ± 20.2 | 73.3 ± 16.9 | 0.080 | 75.8 ± 17.3 | 77.9 ± 18.6 | 0.986 |
| SBP (mm Hg) | 135.5 ± 17.2 | 134.3 ± 14.5 | 0.822 | 134.1 ± 13.3 | 136.4 ± 11.6 | 0.596 |
| DBP (mm Hg) | 83.9 ± 12.4 | 84.7 ± 11.4 | 0.769 | 85.8 ± 11.0 | 82.7 ± 9.9 | 0.762 |
| Fasting serum insulin (µU/mL) | 14.5 ± 6.0 | 18.3 ± 16.4 | 0.325 | 17.5 ± 16.6 | 16.4 ± 16.2 | 0.632 |
| HOMA-IR | 5.7 ± 2.5 | 6.5 ± 7.2 | 0.702 | 6.6 ± 7.2 | 6.2 ± 7.2 | 0.838 |
| HOMA-β (%) | 59.4 ± 41.3 | 88.5 ± 55.9 | 0.024 | 76.6 ± 58.5 | 70.8 ± 52.8 | 0.236 |
| Total cholesterol (mg/dL) | 184.6 ± 31.9 | 183.2 ± 19.7 | 0.848 | 172.8 ± 28.0 | 181.0 ± 33.8 | 0.687 |
| LDL-cholesterol (mg/dL) | 107.0 ± 32.2 | 104.6 ± 20.4 | 0.483 | 99.4 ± 23.9 | 107.2 ± 22.9 | 0.976 |
| HDL-cholesterol (mg/dL) | 48.9 ± 8.8 | 54.2 ± 10.5 | 0.036 | 52.7 ± 7.2 | 54.2 ± 6.8 | 0.001 |
| Triglycerides (mg/dL) | 168.1 ± 82.2 | 140.3 ± 84.3 | 0.160 | 133.4 ± 44.3 | 158.4 ± 104.7 | 0.760 |
| AST (IU/L) | 39.0 ± 17.8 | 27.2 ± 11.5 | < 0.001 | 25.5 ± 9.9 | 31.1 ± 16.9 | 0.075 |
| ALT (IU/L) | 55.9 ± 32.7 | 40.9 ± 27.9 | < 0.001 | 37.1 ± 20.5 | 42.5 ± 29.2 | 0.003 |
| γ-GT (IU/L) | 54.2 ± 34.8 | 37.3 ± 22.6 | < 0.001 | 33.8 ± 18.6 | 37.1 ± 29.2 | 0.003 |
| Uric acid (mg/dL) | 5.9 ± 1.4 | 5.2 ± 1.2 | 0.022 | 5.4 ± 1.4 | 5.3 ± 1.1 | 0.010 |
| Serum creatinine (mg/dL) | 0.73 ± 0.18 | 0.77 ± 0.19 | 0.113 | 0.73 ± 0.18 | 0.72 ± 0.18 | 0.261 |
| Hematocrit (%) | 42.8 ± 4.1 | 45.9 ± 4.9 | < 0.001 | 46.2 ± 5.1 | 46.0 ± 4.9 | < 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.