Characteristics | Baseline | Month 36 | p |
Age (years) | 44±9 | 47±9 | <0.001 |
Male gender, n (%) | 34 (65) | – | – |
Diabetes mellitus, n (%) | 26 (50) | 32 (62) | 0.24 |
Hypertension, n (%) | 26 (50) | 34 (65) | 0.11 |
Metabolic syndrome, n (%) | 35 (67) | 36 (69) | 0.83 |
Body mass index (kg/m2) | 27.4±3.7 | 27.4±3.8 | 0.81 |
Male | 27.7±4.1 | 27.6±3.9 | 0.87 |
Female | 27.0±2.9 | 26.9±3.5 | 0.86 |
Waist circumference (cm) | 92.6±9.1 | 91.3±10.2 | 0.20 |
Male | 94.8±8.5 | 92.9±10.0 | 0.14 |
Female | 88.7±9.1 | 88.4±10.0 | 0.86 |
ALT (IU/l) | 61 (37–100) | 54 (37–74) | 0.015 |
Fasting glucose (mmol/l) | 6.7±2.9 | 6.4±2.1 | 0.52 |
Insulin (pmol/l) | 102 (61–175) | 82 (60–131) | <0.001 |
HOMA-IR (%) | 2.0 (1.2–3.3) | 1.6 (1.2–2.7) | 0.058 |
Total cholesterol (mmol/l) | 5.3±1.3 | 5.2±1.1 | 0.46 |
HDL-cholesterol (mmol/l) | 1.3±0.3 | 1.3±0.3 | 0.69 |
LDL-cholesterol (mmol/l) | 3.0±1.1 | 3.1±0.8 | 0.50 |
Triglycerides (mmol/l) | 1.9 (1.2–2.8) | 1.7 (1.2–2.5) | 0.29 |
TNFα (pg/ml) | 2.4 (1.7–3.2) | 2.3 (1.7–3.5) | 0.33 |
Adiponectin (μg/ml) | 3.9 (2.5–6.2) | 6.4 (4.6–10.4) | <0.001 |
IL-6 (pg/ml) | 1.3 (0.9–2.3) | 1.2 (0.7–2.5) | 0.68 |
Leptin (ng/ml) | 18.5 (11.5–31.2) | 13.0 (7.7–26.8) | 0.003 |
Cytokeratin-18 fragment (U/l) | 355 (237–645) | 358 (216–546) | 0.21 |
Steatosis grade | 1 (1–2) | 2 (1–3) | 0.046 |
Lobular inflammation | 1 (0–1) | 0 (0–1) | 0.006 |
Ballooning | 0 (0–1) | 1 (1–1) | <0.001 |
NAFLD activity score | 2 (2–3) | 3 (2–4) | 0.052 |
Fibrosis stage | 1 (0–1) | 0 (0–1) | 0.70 |
Simple steatosis, n (%) | 13 (25) | 10 (19) | 0.48 |
Borderline NASH, n (%) | 22 (42) | 24 (46) | 0.69 |
NASH, n (%) | 17 (33) | 18 (35) | 0.84 |
Drug use, n (%) | |||
Metformin | 16 (31) | 15 (29) | 0.83 |
Sulphonylurea | 9 (17) | 9 (17) | 1.0 |
Thiazolidinedione | 0 | 1 (2) | 1.0 |
Insulin | 2 (4) | 3 (6) | 1.0 |
Data are presented as mean±SD or median (IQR) unless stated otherwise.
ALT, alanine aminotransferase; HDL, high-density lipoprotein; HOMA-IR, homoeostasis model assessment of insulin resistance; IL-6, interleukin 6; LDL, low-density lipoprotein; NASH, non-alcoholic steatohepatitis; TNFα, tumour necrosis factor α.