Table 1.
Demographics and NAFLD liver histological grading of discovery and validation cohorts†
| Variable | SomaScan | SOMAmer-Pulldown Multiplex MRM Mass Spectrometry | ||
|---|---|---|---|---|
| Cohort | Discovery Cohort A (n=62) | Discovery Cohort B (n=98) | Validation Cohort C (n=71) | Validation Cohort D (n=84) |
| Age, years (SD) | 46 (11) | 48 (13) | 48 (12) | 50 (13) |
| Sex, female – yes (%) | 47 (75) | 69 (70) | 47 (66) | 38 (45)* |
| Diabetes mellitus – yes (%) | 29 (46) | 45 (46) | 41 (58) | 27 (32)* |
| BMI (kg/m2) | 47 (7) | 45 (6) | 46 (7) | 34 (7)*** |
| ALT (U/L) | 44 (37) | 27 (15) | 50 (42) | 74 (40)*** |
| AST (U/L) | 32 (24) | 26 (10) | 35 (28) | 50 (24)** |
| Alkaline phosphatase (U/L) | 91 (22) | 81 (24) | 88 (33) | 80 (27) |
| Total Bilirubin (mg/dL) | 0.5 (0.2) | 0.5 (0.3) | 0.5 (0.2) | 0.7 (0.8) |
| Glucose (mg/dL) | 113 (38) | 105 (31) | 128 (60) | 113 (40) |
| LDL (mg/dL) | 102 (32) | 98 (32) | 101 (36) | 107 (39) |
| HDL (mg/dL) | 52 (13) | 44 (12)* | 45 (16) | 46 (12) |
| Triglycerides (mg/dL) | 172 (100) | 127 (69)* | 157 (80) | 189 (97) |
| Liver Histology – subjects (%) | ||||
| Normal | 4 (6) | 19 (19) | 10 (14) | NA |
| NAFL | 31 (50) | 30 (31) | 8 (11) | 12 (14) |
| NASH Fibrosis Stage 0 | 13 (21) | 9 (9) | 10 (14) | 19 (23) |
| NASH Fibrosis Stage 1 | 5 (8) | 23 (23) | 10 (14) | 12 (14) |
| NASH Fibrosis Stage 2 | 5 (8) | 10 (10) | 18 (25) | 21 (25) |
| NASH Fibrosis Stage 3 | 3 (5) | 5 (5) | 10 (14) | 12 (14) |
| NASH Fibrosis Stage 4 | 1 (2) | 2 (2) | 5 (7) | 8 (10) |
†
Data reported as mean (standard deviation) unless otherwise noted. Significant differences between Cohort A/B and Cohort C/D for demographic data reported using one-way ANOVA for continuous variables and Fisher’s Exact test for categorical variables.
*
p<0.01,
**
p<0.0005,
***
p<0.0001
NAFL: non-alcoholic fatty liver; NASH: non-alcoholic steatohepatitis; ALT: alanine aminotransferase; AST: aspartate aminotransferase; LDL: low-density lipoprotein; HDL: high-density lipoprotein