Table 2.

Estimates of month 4 treatment effects

OutcomeN Month 2N Month 4Overall trt P ValueaExercisebDietbDiet and Exerciseb
BMI, kg/m298920.060.17 (−0.53 to 0.87)−0.55 (−1.22 to 0.12)−0.83 (−1.51 to −0.14)
Weight, kg98920.060.46 (−1.44 to 2.37)−1.80 (−3.62 to 0.01)−2.39 (−4.27 to −0.52)
DEXA body fat, %0760.030.73 (−0.57 to 2.02)−1.58 (−2.89 to −0.28)−0.52 (−1.88 to 0.84)
Waist hip ratio97900.130.01 (−0.02 to 0.03)−0.02 (−0.04 to <0.01)−0.02 (−0.04 to <0.01)
F2-isoprostane, ng/ml0900.03−0.01 (−0.02 to <−0.01)−0.01 (−0.02 to <−0.01)−0.01 (−0.02 to −0.01)
Isofuran, ng/ml0900.72<−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)0860.360.68 (−1.48 to 2.85)0.37 (−1.67 to 2.42)1.87 (−0.28 to 4.02)
IL-6, pg/ml96900.03−4.01 (−6.71 to −1.32)−2.71 (−5.29 to −0.14)−3.83 (−6.46 to −1.20)
IL-10, pg/ml96900.26−0.07 (−0.80 to 0.66)0.64 (−0.06 to 1.34)−0.20 (−0.92 to 0.51)
Systolic BP, mmHg98920.98−1.07 (−8.46 to 6.33)−1.31 (−8.50 to 5.87)0.17 (−7.24 to 7.57)
Diastolic BP, mmHg98920.841.03 (−3.63 to 5.69)−0.29 (−4.79 to 4.22)−1.12 (−5.79 to 3.55)
Urine creatinine, mg/dl0890.50−8.65 (−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 m20890.921.44 (−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.

  • a 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.

  • b 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.