Table 1.
Baseline Demographic, Biochemical, and Histologic Characteristics of Subjects
| N | Aramchol (n=25) | Placebo (n=25) | P-Value | |
|---|---|---|---|---|
| Demographics | ||||
| Age (years) | 50 | 46.6 ± 11.4 | 49.7 ± 9.0 | 0.3002 |
| Male patients | 50 | 22 (88%) | 24 (96%) | 0.6092 |
| White (vs. non-White) | 50 | 11 (44%) | 6 (24%) | 0.1355 |
| Hispanic (vs. non) | 50 | 14 (56%) | 19 (76%) | 0.1355 |
| Clinical | ||||
| Weight (kg) | 50 | 94.7 ± 16.8 | 88.9 ± 16.6 | 0.2196 |
| Height (m) | 49 | 172.4 ± 8.5 | 171.4 ± 7.0 | 0.6601 |
| BMI (kg/m2) | 49 | 31.4 ± 5.0 | 30.1 ± 4.2 | 0.3086 |
| BMI ≥ 30 | 49 | 14 (58.3%) | 9 (36.0 %) | 0.1174 |
| Diabetes | 50 | 2 (8%) | 8 (32%) | 0.0339 |
| Biochemical profile | ||||
| ALT (IU/L) | 50 | 58.0 (55.0) | 43.0 (26.0) | 0.0080 |
| AST (IU/L) | 50 | 42.0 (29.0) | 29.0 (23.0) | 0.0624 |
| AST:ALT | 50 | 0.6 (0.2) | 0.7 (0.2) | 0.0397 |
| Alk Phos (U/L) | 50 | 77.0 (32.0) | 85.0 (40.0) | 0.9536 |
| Total bilirubin (mg/dL) | 50 | 0.6 (0.3) | 0.5 (0.3) | 0.3222 |
| Direct bilirubin (mg/dL) | 47 | 0.2 (0.0) | 0.2 (0.0) | 0.2811 |
| Albumin (g/dL) | 49 | 4.5 (0.4) | 4.5 (0.3) | 0.4240 |
| Protime (s) | 50 | 11.3 (0.9) | 11.3 (0.9) | 0.6903 |
| Triglycerides (mg/dL) | 50 | 166.0 (67.0) | 184.0 (124.0) | 0.3986 |
| Total cholesterol (mg/dL) | 50 | 177.0 (58.0) | 171.0 (36.0) | 0.9690 |
| LDL (mg/dL) | 48 | 109.0 (46.0) | 95.0 (31.0) | 0.4090 |
| FFA (mmol/L) | 49 | 0.5 (0.3) | 0.7 (0.3) | 0.3318 |
| Glucose (mg/dL) | 50 | 98.0 (17.0) | 108.0 (33.0) | 0.2401 |
| Insulin (μU/mL) | 50 | 30.0 (17.0) | 23.0 (25.0) | 0.9831 |
| HOMA-IR | 50 | 7.2 (4.0) | 6.3 (7.3) | 0.7859 |
| Hgb A1C (%) | 48 | 5.5 (0.6) | 5.6 (0.7) | 0.5278 |
| HIV-related | ||||
| CD4 count (cells/mm3) | 48 | 696.0 (351.0) | 680.0 (351.0) | 0.9671 |
| Viral load (copies/ml) | 46 | 0 (0) | 0 (0) | 0.4018 |
| Time since HIV diagnosis (years) | 46 | 14.5 (14) | 18.0 (17) | 0.4343 |
| Imaging | ||||
| MRI PDFF | 50 | 16.2 (10.1) | 12.1 (10.3) | 0.5094 |
| MRE (kPa) | 46 | 2.5 (0.8) | 2.3 (0.7) | 0.4221 |
| VCTE LSM (kPa) | ||||
| Median | 49 | 6.1 (3.0) | 5.5 (3.5) | 0.4831 |
| IQR | 49 | 1.2 (0.7) | 0.7 (1.0) | 0.2211 |
| IQR/M | 49 | 15.0 (12.0) | 11.0 (8.0) | 0.1961 |
| Success rate <60%, n(%) | 48 | 2 (8%) | 4 (17.4%) | 0.9232 |
| Unreliable liver stiffness, n(%) | 50 | 0 | 1(4%) | 1.0000 |
| Controlled attenuation parameter (dB/m) | ||||
| Median | 48 | 334.0 (42.0) | 319.0 (105.0) | 0.6423 |
| IQR | 48 | 33.0 (21.0) | 30.0 (26.0) | 0.7883 |
| Probe size, n(%) | 0.5712 | |||
| Medium | 23 | 11 (44%) | 12 (52.2%) | |
| XL | 25 | 14 (56%) | 11 (47.8%) | |
| Adipose Indices | ||||
| Total Body % Fat | 43 | 31.7 (9.5) | 31.8 (6.8) | 0.4952 |
| Fat Mass/Height2 (kg/m2) | 43 | 9.8 (5.6) | 9.0 (2.7) | 0.1885 |
| Android/Gynoid Ratio | 43 | 1.4 (0.3) | 1.4 (0.5) | 0.2278 |
| % Fat Trunk/% Fat Legs | 43 | 1.3 (0.3) | 1.5 (0.9) | 0.0659 |
| Trunk/Limb Fat Mass Ratio | 43 | 1.6 (0.5) | 1.9 (0.7) | 0.0445 |
| Est. VAT Mass (g) | 43 | 956 (418) | 1051 (299) | 0.6262 |
| Est. VAT Volume (cm3) | 43 | 1033 (452) | 1137 (323) | 0.6262 |
| Est. VAT Area (cm2) | 43 | 198 (87) | 218 (62) | 0.6348 |
| Lean Indices | ||||
| Lean/Height2 (kg/m2) | 43 | 19.7 (3.8) | 19.4 (2.4) | 0.3805 |
| Appen. Lean/Height2 (kg/m2) | 43 | 8.7 (2.1) | 8.1 (1.7) | 0.3122 |
| Metabolic Factors, n(%) | ||||
| Waist >102cm men, > 88cm women | 49 | 15 (62%) | 15 (60%) | 0.8575 |
| Triglycerides ≥ 150 mg/dL | 50 | 14 (56%) | 16 (64%) | 0.5637 |
| HDL < 40mg/dL men, < 50 mg/dl women | 48 | 14 (58%) | 8 (33%) | 0.0822 |
| SBP ≥ 130 and/or DBP ≥ 85 | 50 | 10 (40%) | 12 (48%) | 0.5688 |
| FPG ≥ 100 mg/dL | 50 | 10 (40%) | 16 (64%) | 0.0894 |
| Metabolic Syndrome | 50 | 12 (48%) | 11 (44%) | 0.7766 |
| MRI Body Composition Indices | ||||
| Pericardial Volume (mm3) | 32 | 174700 (117770) | 134100 (63059) | 0.2582 |
| VAT (l) | 44 | 6.3 (2.5) | 6.6 (2.7) | 0.8142 |
| ASAT (l) | 43 | 7.9 (4.6) | 6.8 (5.2) | 0.4963 |
| VAT + ASAT (l) | 43 | 14.3 (4.3) | 14.6 (5.1) | 0.7246 |
| Visceral fat ratio (%) | 43 | 43.4 (15.6) | 46.4 (19.3) | 0.5040 |
| Thigh volume (l) | 40 | 12.8 (3.2) | 11.6 (2.6) | 0.0216 |
| Muscle ratio (kg/l) | 40 | 7.3 (1.0) | 7.5 (2.1) | 0.3918 |
| Fat storage (l/m2) | 42 | 5.0 (1.5) | 4.9 (1.5) | 0.9699 |
| Visceral Fat Index (l/m2) | 43 | 2.1 (0.8) | 2.3 (0.7) | 0.5031 |
| Fat ratio (%) | 39 | 53.3 (8.8) | 53.6 (11.2) | 0.7890 |
BMI, Body Mass Index; AST, Aspartate Aminotransferase; ALT, Alanine Aminotransferase; Hgb A1C, hemoglobin A1C; LDL, Low-Density Lipoprotein; HDL, High-Density Lipoprotein; FFA, Free Fatty Acids; CRP, C-Reactive Protein; ALK Phos, Alkaline Phosphatase; GGT, Gamma-Glutamyl Transferase; HOMA, homeostatic model assessment; LSM, Liver Stiffness Measurement; VAT, Visceral Adipose Tissue; SBP, systolic blood pressure; DBP, diastolic blood pressure; FPG, fasting plasma glucose; ASAT, abdominal subcutaneous adipose tissue.
Muscle ratio = weight/total thigh volume; Fat storage = (VAT + ASAT)/height2; Visceral Fat Index = VAT/height2; Fat ratio = (VAT + ASAT) / (VAT + ASAT + total thigh volume) * 100
Data presented as mean ± sd, median(iqr) or n(%) as appropriate.
T-test performed on continuous variables presented as mean ± sd, Wilcoxon-Mann-Whitney performed on all other continuous/ordinal variables. Chi-square or Fisher’s exact test as appropriate on all categorical variables.
P-values in bold denote statistical significance < 0.05.