Patient characteristics at week 0
| . | EMPA (n = 42) . | Placebo (n = 42) . |
|---|---|---|
| Sex | ||
| Male | 29 (69) | 29 (69) |
| Female | 13 (31) | 13 (31) |
| Age (years) | 62.7 ± 7.0 | 61.5 ± 10.0 |
| Ethnicity | ||
| Caucasian | 42 (100) | 41 (98) |
| Hispanic/Latino | 0 (0) | 1 (2) |
| BMI (kg/m2) | 32.1 ± 4.6 | 32.4 ± 4.2 |
| Known diabetes duration (months) | 36 ± 27 | 40 ± 27 |
| Hepatic steatosis* | 33 (79) | 33 (79) |
| Concomitant medication | ||
| Antihyperglycemic drugs# | 28 (67) | 26 (62) |
| Antihypertensive drugs | 21 (50) | 29 (69) |
| Lipid-lowering drugs | 19 (45) | 15 (36) |
| Glycemia | ||
| HbA1c | ||
| % | 6.8 ± 0.5 | 6.7 ± 0.7 |
| mmol/mol | 51 ± 6 | 50 ± 8 |
| FBG (mmol/L) | 7.5 ± 1.4 | 7.2 ± 1.3 |
| Serum lipid concentrations | ||
| Triglycerides (mg/dL) | 159 (122; 202) | 181 (103; 251) |
| HDL cholesterol (mg/dL) | 50 ± 15 | 48 ± 10 |
| LDL cholesterol (mg/dL) | 133 ± 40 | 120 ± 30 |
| Liver transaminases | ||
| ALT (μmol/s/L) | 0.54 (0.42; 0.80) | 0.62 (0.42; 0.88) |
| AST (μmol/s/L) | 0.42 (0.36; 0.49) | 0.43 (0.37; 0.55) |
| . | EMPA (n = 42) . | Placebo (n = 42) . |
|---|---|---|
| Sex | ||
| Male | 29 (69) | 29 (69) |
| Female | 13 (31) | 13 (31) |
| Age (years) | 62.7 ± 7.0 | 61.5 ± 10.0 |
| Ethnicity | ||
| Caucasian | 42 (100) | 41 (98) |
| Hispanic/Latino | 0 (0) | 1 (2) |
| BMI (kg/m2) | 32.1 ± 4.6 | 32.4 ± 4.2 |
| Known diabetes duration (months) | 36 ± 27 | 40 ± 27 |
| Hepatic steatosis* | 33 (79) | 33 (79) |
| Concomitant medication | ||
| Antihyperglycemic drugs# | 28 (67) | 26 (62) |
| Antihypertensive drugs | 21 (50) | 29 (69) |
| Lipid-lowering drugs | 19 (45) | 15 (36) |
| Glycemia | ||
| HbA1c | ||
| % | 6.8 ± 0.5 | 6.7 ± 0.7 |
| mmol/mol | 51 ± 6 | 50 ± 8 |
| FBG (mmol/L) | 7.5 ± 1.4 | 7.2 ± 1.3 |
| Serum lipid concentrations | ||
| Triglycerides (mg/dL) | 159 (122; 202) | 181 (103; 251) |
| HDL cholesterol (mg/dL) | 50 ± 15 | 48 ± 10 |
| LDL cholesterol (mg/dL) | 133 ± 40 | 120 ± 30 |
| Liver transaminases | ||
| ALT (μmol/s/L) | 0.54 (0.42; 0.80) | 0.62 (0.42; 0.88) |
| AST (μmol/s/L) | 0.42 (0.36; 0.49) | 0.43 (0.37; 0.55) |
Data are mean ± SD for normally distributed parameters, median (25%; 75%) for log-normally distributed parameters, or n (%). ALT, alanine aminotransferase; AST, aspartate aminotransferase.
LFC ≥5.56% measured by magnetic resonance–based methods.
Antihyperglycemic medication was stopped from at least 4 weeks before randomization until the end of the intervention period.