Table 3.
Changes in liver enzymes, serum biochemical tests, metabolic factors, and quality of life from baseline to 52 weeks
| Change from baseline to 52 weeks (mean[SD]) |
Adjusted differences in mean changes from baseline (CBDR vs. placebo) (95% CI) |
P | ||
|---|---|---|---|---|
| CBDR (N=75) |
Placebo (N=77) |
|||
| Liver enzymes | ||||
| Alanine aminotransferase (U/L) | −53 (88) | −8 (77) | −24 (−44, −4) | 0.02 |
| Aspartate aminotransferase (U/L) | −31 (52) | −4 (36) | −15 (−26, −4) | 0.008 |
| Alkaline phosphatase (U/L) | −31 (70) | −19 (54) | −9 (−28, 10) | 0.37 |
| γ-glutamyl transpeptidase (U/L) | −10 (23) | −1 (16) | −7 (−13, −1) | 0.02 |
| Lipids | ||||
| Total cholesterol (mg/dL) | −11 (23) | −4 (22) | −6 (−13, 0) | 0.07 |
| HDL cholesterol (mg/dL) | 0.0 (6.2) | −0.4 (7.6) | −0.6 (−2.7, 1.6) | 0.61 |
| LDL cholesterol (mg/dL) | −10 (19) | −3 (20) | −5 (−11, 1) | 0.09 |
| Non-HDL cholesterol (mg/dL) | −11 (22) | −4 (19) | −6 (−13, 0) | 0.06 |
| Triglycerides (mg/dL) | −7 (60) | 0 (68) | −5 (−25, 14) | 0.59 |
| Metabolic factors | ||||
| Weight (kg) | 6.3 (9.3) | 7.8 (6.6) | −1.5 (−4.1, 1.1) | 0.25 |
| Body-mass index (kg/m2) | 0.8 (2.8) | 1.1 (2.2) | −0.3 (−1.1, 0.5) | 0.42 |
| Body-mass index z-score | −0.1 (0.3) | 0 (0.2) | −0.1 (−0.1, 0.0) | 0.11 |
| Waist circumference (cm) | 2.5 (7.7) | 2.3 (7.5) | 0.2 (−2.3, 2.6) | 0.89 |
| Fasting serum glucose (mg/dL) | 1 (12) | 5 (27) | −4 (−11, 3) | 0.24 |
| Insulin (µU/mL) | 6 (36) | 10 (40) | −6 (−18, 6) | 0.34 |
| HOMA-IR (glucose [mmol/L] x insulin [pmol/L]/22.5) |
1.4 (9.2) | 3.6 (12.5) | −2.6 (−6.2, 1.0) | 0.15 |
| Systolic blood pressure (mm Hg) | 3 (12) | 2 (12) | 1 (−3, 4) | 0.71 |
| Diastolic blood pressure (mm Hg) | −1 (9) | 1 (9) | −1 (−4, 1) | 0.31 |
| Self-Reported Pediatric QOL | ||||
| Physical health | 4 (17) | 5 (16) | −1 (−5, 3) | 0.77 |
| Psychosocial health | 4 (15) | 5 (14) | −1 (−5, 3) | 0.64 |
|
Parent/guardian-Reported Pediatric QOL |
||||
| Physical health | 4 (27) | 5 (24) | −2 (−9, 5) | 0.58 |
| Psychosocial health | 5 (18) | 6 (24) | −1 (−6, 5) | 0.85 |
Data are mean (SD). P-values and differences in means changes from baseline were calculated using ANCOVA models, regressing change from baseline to 52 weeks on treatment group and baseline value of the outcome.
Number of patients in the CBDR group ranged from 70 to 75 and number of patients in the placebo group ranged from 73 to 77 due to missing values.