Table 1.
Baseline Characteristics by Treatment Group
| Mean (SD)a |
||||
|---|---|---|---|---|
| Vitamin E (n = 58) | Metformin (n = 57) | Placebo (n = 58) | Total (N = 173) | |
| Age, y | 13.4 (2.3) | 13.1 (2.4) | 12.9 (2.6) | 13.1 (2.4) |
|
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| Female sex, No. (%) | 11 (19.0) | 10 (17.5) | 12 (20.7) | 33 (19.1) |
|
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| Hispanic ethnicity, No. (%) | 36 (62.1) | 31 (54.4) | 39 (67.2) | 106 (61.3) |
|
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| Race, No. (%) | ||||
| American Indian or Alaska Native | 7 (12.1) | 6 (10.5) | 10 (17.2) | 23 (13.3) |
|
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| Asian | 1 (1.7) | 2 (3.5) | 0 | 3 (1.7) |
|
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| Black or African American | 3 (5.2) | 1 (1.8) | 0 | 4 (2.3) |
|
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| Native Hawaiian or other Pacific Islander | 0 | 0 | 1 (1.7) | 1 (0.6) |
|
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| White | 40 (69.0) | 43 (75.4) | 45 (77.6) | 128 (74.0) |
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| ≥2 Races | 1 (1.7) | 1 (1.8) | 0 | 2 (1.2) |
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| Refusal/not stated | 6 (10.3) | 4 (7.0) | 2 (3.4) | 12 (6.9) |
|
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| Self-reported QOL scoreb | ||||
| Physical health | 78 (17) | 77 (18) | 76 (21) | 77 (19) |
|
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| Psychosocial health | 70 (19) | 71 (16) | 68 (19) | 70 (18) |
|
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| Parent/guardian-reported QOL scoreb | ||||
| Physical health | 66 (23) | 64 (23) | 65 (24) | 65 (23) |
|
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| Psychosocial health | 64 (18) | 62 (19) | 61 (21) | 62 (19) |
|
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| Serum biochemistry tests | ||||
| AST, U/L | 70 (37) | 69 (45) | 74 (42) | 71 (41) |
|
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| ALT, U/L | 121 (65) | 121 (68) | 126 (62) | 123 (65) |
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| GGT, U/L | 50 (25) | 52 (51) | 50 (32) | 51 (37) |
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| Alkaline phosphatase, U/L | 220 (94) | 237 (99) | 229 (93) | 228 (95) |
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| Total bilirubin, mg/dL | 0.68 (0.33) | 0.64 (0.25) | 0.63 (0.32) | 0.65 (0.30) |
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| α-Tocopherol, mg/L | 9.5 (4.9) | 8.4 (2.7) | 9.3 (4.8) | 9.1 (4.3) |
|
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| Lipids | ||||
| Triglycerides, mg/dL | 154 (107) | 151 (103) | 153 (92) | 153 (100) |
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| Total cholesterol, mg/dL | 179 (42) | 174 (45) | 176 (35) | 176 (40) |
|
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| HDL, mg/dL | 37 (9) | 38 (7) | 38 (10) | 38 (9) |
|
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| LDL, mg/dL | 114 (34) | 105 (30) | 108 (27) | 109 (30) |
|
| ||||
| Metabolic characteristics | ||||
| HOMA-IR, mg/dL × μU/mL/405 | 8.6 (7.8) | 7.9 (5.4) | 11.0 (17.6) | 9.2 (11.6) |
|
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| Fasting serum glucose, mg/dL | 87 (8) | 90 (10) | 90 (9) | 89 (9) |
|
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| Weight, kg | 91 (28) | 88 (23) | 86 (24) | 88 (25) |
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| Waist circumference, cm | 108 (18) | 104 (13) | 105 (12) | 105 (15) |
|
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| BMIc | 34 (7) | 34 (5) | 33 (6) | 34 (6) |
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| BMI z score | 2.33 (0.34) | 2.35 (0.30) | 2.35 (0.26) | 2.35 (0.30) |
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| Body composition, % total fatd | 44 (6) | 44 (7) | 43 (7) | 43 (6) |
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| Tanner stagee | 2.6 (1.5) | 2.6 (1.4) | 2.5 (1.5) | 2.6 (1.4) |
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| Liver histology | ||||
| Fibrosis stage | 1.2 (1.0) | 1.3 (1.0) | 1.2 (1.0) | 1.2 (1.0) |
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| Definite NASH, No. (%) | 27 (46.6) | 24 (42.1) | 22 (37.9) | 73 (42.2) |
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| Steatosis score | 2.3 (0.8) | 2.1 (0.8) | 2.1 (0.8) | 2.2 (0.8) |
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| Lobular inflammation score | 1.6 (0.6) | 1.6 (0.6) | 1.7 (0.6) | 1.6 (0.6) |
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| Ballooning degeneration score | 1.0 (0.8) | 0.8 (0.8) | 0.8 (0.8) | 0.8 (0.8) |
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| ||||
| NAFLD activity score | 4.8 (1.6) | 4.5 (1.2) | 4.6 (1.3) | 4.6 (1.4) |
Abbreviations: ALT, alanine aminotransferase; AST, aspartate aminotransferase; BMI, body mass index; GGT, γ-glutamyltransferase; HDL, high-density lipoprotein cholesterol; HOMA-IR, homeostasis model assessment of insulin resistance; LDL, low-density lipoprotein cholesterol; NAFLD, nonalcoholic fatty liver disease; NASH, nonalcoholic steatohepatitis; QOL, quality of life.
SI conversion factors: To convert AST, ALT, GGT, and alkaline phosphatase to μkat/L, multiply by 0.0167; to convert total bilirubin to μmol/L, multiply by 17.104; to convert α-tocopherol to μmol/L, multiply by 23.22; to convert triglycerides to mmol/L, multiply by 0.0113; to convert total, HDL, and LDL cholesterol to mmol/L, multiply by 0.0259; and to convert glucose to mmol/L, multiply by 0.0555.
Except where otherwise noted.
Pediatric Quality of Life Inventory (version 4.0) scores were recoded to range from 0 to 100, with increasing scores indicating better quality of life.
Calculated as weight in kilograms divided by height in meters squared.
Three patients, 1 assigned to each group, were too obese to be assessed. Their values were imputed with the 95th percentile value.
Tanner stage was defined using genital stage for boys and breast stage for girls.