Table 3. Outcomes and percentage changes in parameters from baseline to 12 weeks.
| YH1 Group | Placebo Group | p value | |
|---|---|---|---|
| (n = 21) | (n = 20) | ||
| median (min, max) | median (min, max) | ||
| Weight (kg) | |||
| At week 12 | 73.6 (57.7, 108.2) | 74.3 (60.9, 87.6) | |
| Relative change (%) | -0.5 (-3.2, 1.7) | 0.6 (-1.7, 4.2) | 0.030* |
| Waist circumference (cm) | |||
| At week 12 | 90.5 (79.0, 112.5) | 93.3 (81.5, 105.5) | |
| Relative change (%) | -1.1 (-4.1, 2.2) | 0.5 (-2.8, 3.2) | 0.012* |
| Body mass index (kg/m2) | |||
| At week 12 | 26.1 (23.1, 35.6) | 28.3 (22.8, 35.5) | |
| Relative change (%) | -0.4 (-3.3, 1.7) | 0.4 (-1.8, 4.0) | 0.083 |
| HbA1c (%) | |||
| At week 12 | 7.6 (6.0, 9.3) | 8.7 (7.8, 10.2) | |
| Relative change (%) | -11.1 (-30.2, 14.1) | 0.0 (-20.4, 7.3) | 0.008** |
| FPG (mg/dL) | |||
| At week 12 | 136.0 (83.0, 223.0) | 167.5 (112.0, 261.0) | |
| Relative change (%) | -12.0 (-54.1, 51.7) | 5.0 (-27.3, 72.4) | 0.066 |
| 2hPG (mg/dL) | |||
| At week 12 | 172.0 (75.0, 286.0) | 253.0 (152.0, 355.0) | |
| Relative change (%) | -26.2 (-60.3, 94.1) | 5.1 (-43.0, 90.6) | 0.006** |
| Fasting insulin (μU/mL) | |||
| At week 12 | 8.8 (2.7, 21.7) | 6.1 (2.8, 14.5) | |
| Relative change (%) | 12.9 (-46.1, 185.5) | 1.0 (-55.1, 69.4) | 0.157 |
| HOMA-IR | |||
| At week 12 | 3.4 (0.9, 9.0) | 2.7 (0.9, 7.4) | |
| Relative change (%) | 10.9 (-68.8, 201.3) | -3.1 (-64.8, 108.2) | 0.928 |
| HOMA-β | |||
| At week 12 | 45.4 (13.7, 230.4) | 20.2 (9.2, 72.0) | |
| Relative change (%) | 68.9 (-59.5, 399.2) | -1.4 (-63.2, 116.7) | 0.001** |
| Total cholesterol (mg/dL) | |||
| At week 12 | 152.0 (90.0, 213.0) | 172.0 (105.0, 238.0) | |
| Relative change (%) | -21.6 (-38.9, 8.1) | -5.6 (-27.8, 58.2) | 0.004** |
| HDL-C (mg/dL) | |||
| At week 12 | 41.0 (27.0, 59.0) | 43.0 (30.0, 56.0) | |
| Relative change (%) | -9.3 (-26.2, 13.9) | -3.1 (-18.6, 20.5) | 0.059 |
| LDL-C (mg/dL) | |||
| At week 12 | 86.0 (44.0, 152.0) | 107.5 (44.0, 170.0) | |
| Relative change (%) | -17.4 (-54.1, 48.3) | -5.7 (-27.9, 83.6) | 0.023* |
| Triglyceride (mg/dL) | |||
| At week 12 | 109.0 (44.0, 347.0) | 180.0 (49.0, 286.0) | |
| Relative change (%) | -29.5 (-60.7, 32.0) | 5.2 (-67.8, 59.5) | 0.004** |
| Triglyceride/HDL-C | |||
| At week 12 | 2.4 (1.3, 10.2) | 4.5 (1.0, 9.5) | |
| Relative change (%) | -25.8 (-62.3, 27.5) | 0.2 (-64.9, 85.9) | 0.051 |
| Score of TCM symptoms of diabetes | |||
| At week 12 | 1.0 (0.0, 9.0) | 3.0 (0.0, 9.0) | |
| Relative change (%) | -80.0 (-0.0, 16.7) | -58.6 (-100.0, 66.7) | 0.107 |
The data are presented as the median (min, max). Statistics were evaluated by using the Mann–Whitney U test for continuous variables (*p < 0.05, **p < 0.01). After 12 weeks of YH1 treatment, there were significant reductions in body weight, waist circumference, HbA1c, 2hPG, triglyceride, total cholesterol, and LDL-C. A significant increase in HOMA-β was observed in the YH1 group. There were trends of decreased FBG and TG/HDL-C levels in the YH1 group, but the differences were not significant. Relative changes in HOMA-IR and TCM symptom scores showed no significant differences between groups. HbA1c, glycated hemoglobin; FPG, fasting plasma glucose; 2hPG, 2-hour postprandial glucose; HOMA-IR, homeostatic model assessment of insulin resistance; HOMA-β, homeostatic model assessment of β cell function; HDL-C, high-density lipoprotein cholesterol; LDL-C, low-density lipoprotein cholesterol; TCM, traditional Chinese medicine.