Table 2.
Estimates of month 4 treatment effects
| Outcome | N Month 2 | N Month 4 | Overall trt P Valuea | Exerciseb | Dietb | Diet and Exerciseb |
|---|---|---|---|---|---|---|
| BMI, kg/m2 | 98 | 92 | 0.06 | 0.17 (−0.53 to 0.87) | −0.55 (−1.22 to 0.12) | −0.83 (−1.51 to −0.14) |
| Weight, kg | 98 | 92 | 0.06 | 0.46 (−1.44 to 2.37) | −1.80 (−3.62 to 0.01) | −2.39 (−4.27 to −0.52) |
| DEXA body fat, % | 0 | 76 | 0.03 | 0.73 (−0.57 to 2.02) | −1.58 (−2.89 to −0.28) | −0.52 (−1.88 to 0.84) |
| Waist hip ratio | 97 | 90 | 0.13 | 0.01 (−0.02 to 0.03) | −0.02 (−0.04 to <0.01) | −0.02 (−0.04 to <0.01) |
| F2-isoprostane, ng/ml | 0 | 90 | 0.03 | −0.01 (−0.02 to <−0.01) | −0.01 (−0.02 to <−0.01) | −0.01 (−0.02 to −0.01) |
| Isofuran, ng/ml | 0 | 90 | 0.72 | <−0.01 (−0.01 to 0.01) | −0.01 (−0.02 to 0.01) | <−0.00 (−0.02 to 0.01) |
| VO2 peak, ml/(kg·min) | 0 | 86 | 0.36 | 0.68 (−1.48 to 2.85) | 0.37 (−1.67 to 2.42) | 1.87 (−0.28 to 4.02) |
| IL-6, pg/ml | 96 | 90 | 0.03 | −4.01 (−6.71 to −1.32) | −2.71 (−5.29 to −0.14) | −3.83 (−6.46 to −1.20) |
| IL-10, pg/ml | 96 | 90 | 0.26 | −0.07 (−0.80 to 0.66) | 0.64 (−0.06 to 1.34) | −0.20 (−0.92 to 0.51) |
| Systolic BP, mmHg | 98 | 92 | 0.98 | −1.07 (−8.46 to 6.33) | −1.31 (−8.50 to 5.87) | 0.17 (−7.24 to 7.57) |
| Diastolic BP, mmHg | 98 | 92 | 0.84 | 1.03 (−3.63 to 5.69) | −0.29 (−4.79 to 4.22) | −1.12 (−5.79 to 3.55) |
| Urine creatinine, mg/dl | 0 | 89 | 0.50 | −8.65 (−42.17 to 24.86) | 6.54 (−26.13 to 39.21) | −18.51 (−51.89 to 14.87) |
| eGFRcysC, ml/min per 1.73 m2 | 0 | 89 | 0.92 | 1.44 (−3.42 to 6.36) | −0.02 (−4.75 to 4.71) | 0.15 (−4.73 to 5.04) |
trt, treatment; DEXA, dual energy x-ray absorptiometry.
Treatment effect P value refers to a joint (or chunk) test of overall treatment effect, including month 2 effects if month 2 data are available.
The table reports month 4 treatment effect (95% confidence interval). The effect is estimated as the mean month 4 outcome in the treatment arm minus the mean month 4 outcome in the placebo arm. The estimates and 95% confidence intervals are derived from a linear mixed model that controls for baseline characteristics (age, sex, BMI, diabetes status, and baseline outcome measure) and trial characteristics (study site) and included a random intercept for study site and treatment arm. When month 2 data were available, the model also included a time variable and a time by treatment interaction along with a subject-specific random intercept.