Table 2.
Primary and secondary outcomes from baseline, with differences adjusted for baseline values using intention-to-treat analyses with last observation carried forward.
| Outcome | N | Placebo Δ [mean (SD)] | Topiramate Δ [mean (SD)] | Mean Difference [Topiramate-Placebo] (95% CI) | P-value |
|---|---|---|---|---|---|
| Percentage Change in BMI | 30 | −0.85 (5.31) | −2.74 (3.74) | −1.85 (−5.21, 1.52) | 0.291 |
| Change in BMI | 30 | −0.30 (2.05) | −1.16 (1.58) | −0.81 (−2.15, 0.53) | 0.244 |
| Change in BMI z-score | 30 | −0.04 (0.11) | −0.07 (0.07) | −0.04 (−0.11, 0.02) | 0.206 |
| Change in Percentage of the 95th BMI Percentile | 30 | −2.55 (6.99) | −6.20 (5.65) | −3.78 (−8.55, 0.99) | 0.132 |
| Change in Weight (kg) | 30 | −0.46 (5.63) | −2.89 (4.92) | −2.07 (−5.80, 1.65) | 0.285 |
| Percentage Change in Weight | 30 | −0.37 (5.45) | −2.18 (4.00) | −1.54 (−4.94, 1.85) | 0.380 |
| Change in Total Body Fat Mass (kg) | 30 | 0.32 (4.07) | −1.51 (3.81) | −1.30 (−4.21, 1.61) | 0.388 |
| Change in % Body Fat | 30 | 0.32 (1.82) | −0.63 (1.46) | −0.57 (−1.83, 0.68) | 0.377 |
| Change in Visceral Fat Mass (g) | 30 | 70.57 (168.36) | −95.75 (197.02) | −160.09 (−296.93, −23.25) | 0.030 |
| Change in Lean Body Mass (kg) | 30 | −0.36 (1.80) | −0.06 (2.19) | 0.22 (−1.38, 1.83) | 0.787 |
| Change in Systolic BP (mmHg) | 30 | −1.86 (8.70) | −2.63 (10.71) | −0.18 (−5.83, 5.47) | 0.951 |
| Change in Diastolic BP (mmHg) | 30 | 0.00 (9.32) | 0.94 (6.87) | 1.45 (−3.76, 6.66) | 0.590 |
| Change in Heart Rate (bpm) | 30 | 3.71 (9.62) | 2.25 (10.53) | 0.09 (−6.60, 6.79) | 0.978 |
| Change in Glucose (mg/dL) | 30 | 3.07 (12.55) | −4.69 (12.35) | −6.23 (−14.09, 1.62) | 0.131 |
| Change in Insulin (mg/dL) | 30 | 7.36 (18.02) | −3.94 (10.28) | −10.16 (−20.91, 0.59) | 0.075 |
| Change in Total Cholesterol (mg/dL) | 30 | −10.79 (17.65) | −7.94 (17.78) | 1.25 (−11.33, 13.83) | 0.847 |
| Change in LDL-c (mg/dL) | 29* | −12.36 (14.60) | −4.60 (13.60) | 7.27 (−3.33, 17.88) | 0.190 |
| Change in HDL-c (mg/dL) | 30 | −1.29 (6.46) | 1.38 (5.99) | 1.76 (−2.62, 6.14) | 0.438 |
| Change in VLDL-c (mg/dL) | 29 | 6.21 (14.02) | −3.53 (8.16) | −9.40 (−17.81, −0.99) | 0.038 |
| Change in Triglycerides (mg/dL) | 30 | 13.64 (56.14) | −28.88 (51.19) | −29.01 (−60.67, 2.65) | 0.084 |
| Change in ALT (mg/dL) | 30 | −3.21 (12.72) | −2.69 (12.28) | −0.61 (−9.65, 8.43) | 0.896 |
| Change in AST (mg/dL) | 30 | −2.29 (9.14) | −1.81 (6.27) | −0.66 (−6.14, 4.81) | 0.814 |
*
unable to measure one participant due to high triglycerides