Table 1.
Baseline Profile of Patients.
| Metadoxine, N = 75 | Placebo, N = 59 | |
|---|---|---|
| Sex: males, N (%) | 52 (69.3) | 43 (72.9) |
| Age; years (mean ± SD) | 39.8 ± 10.4 | 41.1 ± 8.5 |
| BMI, kg/M2 (mean ± SD) | 26.8 ± 3.8 | 27.0 ± 3.9 |
| Normal, N (%) | 11 (14.7) | 6 (10.2) |
| Overweight, N (%) | 13 (17.3) | 15 (25.4) |
| Obese, N (%) | 51 (68.0) | 38 (64.4) |
| Waist circumference, cm (mean ± SD) | 92.9 ± 8.8 | 93.0 ± 7.2 |
| Domicile: rural, N (%) | 53 (70.7) | 41 (69.5) |
| ALT, U/L (median [RIQ]) | 80.0 [55.5, 128.0] | 83.5 [55.5, 129.3] |
| AST, U/L (median [RIQ]) | 54.0 [38.0, 76.5] | 62.0 [38.0, 80.5] |
| Alkaline phosphatase. U/L (median [RIQ]) | 112.0 [71.5, 187.5] | 107.0 [69.5, 175.5] |
| GGT, U/L (median [RIQ]) | 46.5 [32.0, 64.4] | 43.2 [34.1, 52.5] |
| Bilirubin, mg/dL (median [RIQ]) | 0.86 [0.60, 1.15] | 0.80 [0.60, 1.39] |
| Fasting glucose, mg/dL (mean ± SD) | 100.6 ± 28.6 | 102.8 ± 31.5 |
| Serum insulin, mU/L (median [RIQ]) | 11.2 [8.2, 18.3] | 10.8 [6.1, 17.8] |
| HOMA-IR (median [RIQ]) | 2.58 [1.81, 4.68] | 2.26 [1.43, 5.84] |
| HOMA-β function (median [RIQ]) | 125.6 [103.1, 186.8] | 107.8 [66.5, 258.1] |
| Steatosis, N (%): absent | 11 (14.7) | 13 (22.0) |
| Mild | 16 (21.3) | 20 (33.9) |
| Moderate | 46 (61.3) | 24 (40.7) |
| Severe | 2 (2.7) | 2 (3.4) |
| Necro-inflammatory grade, N (%): | ||
| 0 | 1 (1.3) | 0 (0.0) |
| 1 | 26 (34.7) | 21 (35.6) |
| 2 | 29 (38.7) | 27 (45.8) |
| 3 | 18 (24.0) | 11 (18.6) |
| Undetermined | 1 (1.3) | 0 (0.0) |
| Fibrosis stage, N (%): | ||
| 0 | 34 (45.3) | 29 (49.2) |
| 1 | 16 (21.3) | 13 (22.0) |
| 2 | 20 (26.7) | 14 (23.7) |
| 3 | 4 (5.3) | 3 (5.1) |
| Undetermined | 1 (1.3) | 0 (0.0) |
BMI: body mass index; ALT: alanine transaminase; AST: aspartate transaminase; GGT: gamma-glutamyl transferase; HOMA-IR: homeostasis model assessment for insulin resistance computed as [glucose (mg/dL) × insulin (mU/L)]/405; RIQ: range interquartile (25th, 75th percentile).