Table 3.
Changes in laboratory and imaging variables from baseline during the trial
|
Parameter
|
Baseline
|
6 mo
|
P
value
|
| ТС (total sample), mmol/L | 6.03 ± 1.36 | 5.76 ± 1.21 | < 0.001 |
| Men | 5.99 ± 1.39 | 5.77 ± 1.24 | 0.003 |
| Women | 6.11 ± 1.32 | 5.73 ± 1.16 | 0.019 |
| LDL (total sample), mmol/L | 3.86 ± 1.01 | 3.66 ± 0.91 | < 0.001 |
| Men | 3.81 ± 1.04 | 3.67 ± 0.90 | 0.033 |
| Women | 4.0 ± 0.94 | 3.65 ± 0.93 | 0.006 |
| HDL (total sample), mmol/L | 1.24 ± 0.32 | 1.24 ± 0.27 | 0.910 |
| Men | 1.24 ± 0.33 | 1.21 ± 0.22 | 0.160 |
| Women | 1.23 ± 0.29 | 1.31 ± 0.34 | 0.036 |
| TG (total sample), mmol/L | 3.18 (2.00; 4.29) | 2.04 (1.40; 3.16) | < 0.001 |
| Men | 3.13 (2.10; 4.29) | 2.04 (1.4; 2.79) | < 0.001 |
| Women | 3.45 (1.80; 4.36) | 2.26 (1.35; 3.62) | < 0.001 |
| FLI (total sample) | 84.9 ± 10.4 | 72.3 ± 17.6 | < 0.001 |
| Men | 86.3 ± 9.0 | 73.6 ± 17.2 | < 0.001 |
| Women | 81.9 ± 12.7 | 69.4 ± 18.4 | < 0.001 |
| FLI (total sample) ≥ 60/30-59/< 30 | 174 (100)/-/- | 133 (76.4)/40 (23.0)/1 (0.6) | < 0.001 |
| Men | 121 (100)/-/- | 96 (79)/24 (20)/1 (1) | < 0.001 |
| Women | 53 (100)/-/- | 37 (70)/16 (30)/- | < 0.001 |
| NFS (total sample) < -1.455 (F0-F2), n (%) | 141 (81.0) | 148 (85.0) | 0.353 |
| Men | 102 (84.3) | 112 (92.6) | 0.071 |
| Women | 39 (76.6) | 34 (64.2) | 0.402 |
| FIB 4 (total sample) < 1.45 (F0-F1), n (%) | 157 (90.2) | 163 (93.7) | 0.256 |
| Men | 111 (91.7) | 114 (94.2) | 0.615 |
| Women | 46 (86.8) | 49 (92.5) | 0.402 |
| CIMT (total sample), mm | 0.985 ± 0.243 | 0.968 ± 0.237 | 0.013 |
| Men | 0.993 ± 0.224 | 0.977 ± 0.217 | 0.073 |
| Women | 0.967 ± 0.284 | 0.947 ± 0.276 | 0.052 |
| CIMT (total sample) exceeding ULN for the corresponding age and sex | 143 (84) | 139 (82) | 0.549 |
| Men | 103 (85.1) | 101 (83.5) | 0.860 |
| Women | 40 (75.5) | 38 (72) | 0.826 |
| ASCVD (total sample, n = 112) 10-year risk | 5.1 (2.9; 9.1) | 4.8 (2.6; 8.0) | 0.053 |
| Men (n = 71) | 6.0 (3.6; 11.1) | 5.8 (3.4; 8.8) | 0.720 |
| Women (n = 41) | 3.5 (2.3; 7.8) | 3.2 (2.0; 6.0) | 0.003 |
| ASCVD (total sample, n = 152) lifetime risk | 50 (39; 60) | 50 (39; 64) | 0.370 |
| Men (n = 112) | 50 (46; 69) | 50 (46; 69) | 0.870 |
| Women (n = 40) | 39 (39; 50) | 39 (39; 50) | 0.160 |
Data are presented as median (IQR) or n (%). ТС: Total cholesterol; LDL: Low-density lipoprotein; HDL: High-density lipoprotein; TG: Triglyceride; FLI: Fatty liver index; NFS: Nonalcoholic fatty liver disease fibrosis score; FIB-4: Liver fibrosis index; ULN: Upper limit of normal; ASCVD: Atherosclerotic Cardiovascular Disease.