Table 1.
Clinical characteristics.a.
| Baseline (n = 20) | Week 4 (n = 20) | Week 24 (n = 20) | p-value (Baseline vs Week 4) | p-value (Baseline vs Week 24) | |
|---|---|---|---|---|---|
| Age [years] | 49 ± 11a | – | – | – | – |
| Female | 8 (40%) | – | – | – | – |
| Hispanic Ethnicity | 12 (60%) | – | – | – | – |
| Diabetes | 4 (20%) | ||||
| Liver Histology | |||||
| NASH vs Steatosis | 11/9 (55%/45%) | – | – | - | - |
| Cirrhosis | 2 (10%) | – | – | - | - |
| NAFLD Activity Score (NAS)b | 3.5 ± 1.3 | 2.8 ± 1.3 | – | 0.04 | – |
| Portal Inflammation | 0.9 ± 0.6 | 0.8 ± 0.5 | – | 0.73 | – |
| Lobular Inflammation | 1.5 ± 0.7 | 1.2 ± 0.4 | – | 0.19 | – |
| Ballooning | 0.7 ± 0.6 | 0.6 ± 0.5 | – | >0.99 | – |
| Mallory Bodiesc | 1.1 ± 1.3 | 0.8 ± 1.2 | – | 0.42 | – |
| Steatosis | 1.5 ± 0.8 | 1.0 ± 0.9 | – | 0.02 | – |
| Fibrosis | 1.3 ± 1.4 | 1.4 ± 1.1 | – | >0.99 | – |
| BMI [kg/m2] | 33.3 ± 6.9 | 33.4 ± 7.0 | 33.7 ± 6.8 | >0.99 | 0.36 |
| IHTG (%) | 15.6 ± 10.1 | 14.9 ± 10.7 | 12.6 ± 8.6 | >0.99 | 0.41 |
| ALT [U/L] | 43 ± 24 | 34 ± 19 | 29 ± 14 | 0.08 | 0.003 |
| Glucose [mg/dL] | 107.2 ± 15.9 | 106.0 ± 19.6 | 107.2 ± 20.8 | >0.99 | >0.99 |
| Serum αT [μmol/L] | 27.8 ± 7.2 | 56.6 ± 18.3 | 60.8 ± 25.7d | <0.0001 | <0.0001 |
a
Data expressed as mean ± SD or n (%). Semi-quantitative histology scores presented as mean ± SD to facilitate assessment of effect size. Significance testing was performed using non-parametric Wilcoxon signed-rank test.
b
Histological scoring using NASH-CRN scores. One week 4 sample was too small for scoring.
c
Mallory bodies scored semi-quantitatively (0–4).
d
Vitamin E not quantified in one hemolyzed sample.