Table 1.
Adult patients with diabetes and NAFLD: baseline characteristics by the presence of NASH and presence of advanced fibrosis
| Characteristics | Presence of NASH | P* (NASH vs. not NASH) | Presence of advanced fibrosis | |||
|---|---|---|---|---|---|---|
| No (n = 105) | Yes (n = 241) | No: none, mild, or moderate (n = 204) | Yes: bridging or cirrhosis (n = 142) | P* (advanced fibrosis vs. not advanced fibrosis) | ||
| Demographics | ||||||
| Male, n (%) | 38 (36.2) | 68 (28.2) | 0.16 | 62 (30.4) | 44 (31.0) | 0.91 |
| Age (years), mean ± SD | 51.7 ± 10.0 | 52.8 ± 10.4 | 0.37 | 50.3 ± 11.2 | 55.7 ± 7.9 | <0.0001 |
| White, n (%) | 83 (79.0) | 200 (83.0) | 0.45 | 163 (79.9) | 120 (84.5) | 0.32 |
| Hispanic, n (%) | 8 (7.6) | 23 (9.5) | 0.68 | 21 (10.3) | 10 (7.0) | 0.34 |
| Clinical, n (%) | ||||||
| Hypertension | 26 (24.8) | 98 (40.7) | 0.005 | 61 (29.9) | 63 (44.4) | 0.006 |
| Metabolic syndrome§ | 76 (72.4) | 206 (85.5) | 0.006 | 165 (80.9) | 117 (82.4) | 0.78 |
| Acanthosis nigricans§§ | 14 (13.3) | 41 (17.0) | 0.43 | 34 (16.7) | 21 (14.8) | 0.66 |
| Anthropometric, mean ± SD | ||||||
| BMI (kg/m2) | 35.1 ± 6.9 | 36.2 ± 6.8 | 0.17 | 35.5 ± 6.6 | 36.4 ± 7.1 | 0.24 |
| Waist (cm) | 112.3 ± 14.8 | 113.4 ± 14.7 | 0.49 | 112.4 ± 14.0 | 114.1 ± 15.7 | 0.28 |
| Waist-to-hip ratio | 0.95 ± 0.08 | 0.95 ± 0.08 | 0.72 | 0.95 ± 0.07 | 0.95 ± 0.08 | 0.38 |
| Laboratory measures, mean ± SD | ||||||
| AST (units/L) | 36.4 ± 17.0 | 65.6 ± 46.8 | <0.0001 | 52.6 ± 45.2 | 62.8 ± 37.2 | 0.02 |
| ALT (units/L) | 51.5 ± 33.5 | 80.9 ± 59.8 | <0.0001 | 71.9 ± 59.6 | 72.0 ± 47.3 | 0.98 |
| AST-to-ALT ratio | 0.82 ± 0.37 | 0.88 ± 0.32 | 0.12 | 0.78 ± 0.28 | 0.98 ± 0.389 | <0.0001 |
| Alkaline phosphatase (units/L) | 86.9 ± 35.4 | 95.2 ± 41.3 | 0.06 | 86.8 ± 31.4 | 101.0 ± 49.2 | 0.002 |
| Isolated abnormal alkaline phosphatase§§§ | 9 (8.6) | 6 (2.5) | 0.02 | 8 (3.9) | 7 (4.9) | 0.79 |
| GGT (units/L) | 70.4 ± 94.2 | 98.7 ± 124.0 | 0.02 | 70.7 ± 86.7 | 118.0 ± 144.8 | 0.0006 |
| Globulin (g/dL) | 3.06 ± 0.52 | 3.13 ± 0.53 | 0.25 | 3.05 ± 0.52 | 3.19 ± 0.54 | 0.01 |
| Albumin (g/dL) | 4.15 ± 0.41 | 4.21 ± 0.43 | 0.22 | 4.26 ± 0.42 | 4.16 ± 0.43 | 0.18 |
| Total bilirubin (mg/dL) | 0.71 ± 0.43 | 0.67 ± 0.31 | 0.42 | 0.66 ± 0.36 | 0.71 ± 0.34 | 0.17 |
| Direct bilirubin (mg/dL) | 0.15 ± 0.11 | 0.15 ± 0.08 | 0.84 | 0.14 ± 0.08 | 0.16 ± 0.10 | 0.01 |
| INR | 1.02 ± 0.20 | 1.05 ± 0.22 | 0.28 | 1.00 ± 0.19 | 1.09 ± 0.23 | 0.0003 |
| Hematocrit (%) | 40.5 ± 3.9 | 41.1 ± 3.9 | 0.74 | 41.2 ± 3.8 | 40.4 ± 4.0 | 0.06 |
| White blood cells (1,000/mm3) | 7.18 ± 2.3 | 7.23 ± 2.1 | 0.87 | 7.51 ± 2.1 | 6.79 ± 2.1 | 0.002 |
| Platelet count (1,000/mm3) | 240.1 ± 80.7 | 223.9 ± 71.9 | 0.08 | 252.8 ± 71.1 | 194.3 ± 66.5 | <0.0001 |
| Total cholesterol (mg/dL) | 178.2 ± 41.1 | 192.1 ± 44.3 | 0.005 | 191.1 ± 44.4 | 183.3 ± 42.4 | 0.10 |
| HDL cholesterol (mg/dL) | 41.5 ± 11.2 | 41.7 ± 10.7 | 0.88 | 41.2 ± 10.3 | 42.2 ± 11.6 | 0.37 |
| LDL cholesterol (mg/dL) | 105.8 ± 34.6 | 114.2 ± 36.5 | 0.04 | 114.8 ± 36.5 | 107.2 ± 35.2 | 0.05 |
| Triglycerides (mg/dL) | 164.9 ± 76.7 | 190.0 ± 93.3 | 0.01 | 187.4 ± 88.0 | 175.2 ± 90.7 | 0.21 |
| HbA1c (%) | 6.8 ± 1.2 | 7.4 ± 1.3 | 0.006 | 7.14 ± 1.31 | 7.25 ± 1.28 | 0.93 |
| HbA1c (mmol/L) | 50.9 ± 13.2 | 56.9 ± 14.2 | 0.0003 | 54.6 ± 14.3 | 55.7 ± 14.0 | 0.45 |
| Serum glucose (mg/dL) | 124.7 ± 38.2 | 138.6 ± 52.3 | 0.006 | 132.3 ± 48.1 | 137.4 ± 49.9 | 0.35 |
| Serum insulin (µU/mL) | 23.7 ± 15.9 | 32.5 ± 34.4 | 0.001 | 25.3 ± 23.1 | 36.4 ± 37.4 | 0.002 |
| HOMA-IR (mg/dL × µU/mL/405) | 7.2 ± 5.0 | 11.4 ± 13.7 | 0.002 | 8.42 ± 9.0 | 12.6 ± 14.8 | 0.003 |
| Ferritin (ng/mL) | 166.3 ± 169.2 | 249.1 ± 322.9 | 0.002 | 212.6 ± 269.7 | 240.2 ± 311.5 | 0.39 |
| Histology, n (%) | ||||||
| Steatosis ≥34% | 48 (45.7) | 153 (63.5) | 0.003 | 131 (64.2) | 70 (49.3) | 0.008 |
| Lobular inflammation ≥grade 2 | 29 (27.6) | 143 (59.3) | <0.0001 | 100 (49.0) | 72 (50.7) | 0.50 |
| Ballooning: any | 25 (23.8) | 241 (100.0) | <0.0001 | 135 (66.2) | 131 (92.2) | <0.0001 |
| Fibrosis stage: bridging or cirrhosis | 21 (20.0) | 121 (50.2) | <0.0001 | 102 (50.0) | 84 (59.2) | 0.03 |
| NAS, mean ± SD | 3.06 ± 1.12 | 5.39 ± 1.32 | <0.001 | 4.52 ± 1.70 | 4.92 ± 1.56 | 0.09 |
| NAS ≥5, n (%) | 11 (10.5) | 175 (72.6) | <0.0001 | 120 (58.8) | 121 (85.2) | <0.0001 |
Note: patients are from the NASH CRN cohort studies (Database and DB2) enrolled between September 2004 and December 2012. Diagnosis of definite NASH and advanced fibrosis was determined by central review of liver biopsies by the NASH CRN Pathology Committee. NAS, NAFLD activity score.
*P values determined from Fisher exact test for categorical variables or from t test for continuous variables.
§National Cholesterol Education Program definition.
§§0 = absent, 1 = present on close inspection, 2 = mild, 3 = moderate, 4 = severe.
§§§Defined as alkaline phosphatase ≥1 upper limit of normal (ULN), AST < 1 ULN, and ALT < 1 ULN according to local reference ranges.