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. 2021 Apr 28;13(1):75–84. doi: 10.1007/s13340-021-00506-5

Table 2.

Results of key secondary endpoints for the FAS

Variable Treatment group Mean at baseline (SD) [n] Mean at week 13 (SD) [n] LS mean change from baseline at week 13a Estimated differencea,b (95% CI) p valuea,b
FBG, mg/dL Supervised exercise 147.5 (27.8) [109] 143.0 (25.7) [97] − 6.1 − 13.0 (− 19.2,  − 6.7)  < 0.001
Standard therapy 151.4 (30.5) [114] 155.3 (28.7) [107] 6.9
Glycoalbumin, % Supervised exercise 19.32 (2.94) [110] 18.57 (3.15) [97] − 0.75 − 1.52 (− 2.10,  − 0.93)  < 0.001
Standard therapy 19.75 (2.99) [114] 20.18 (3.19) [108] 0.77
Fasting insulin, µIU/mL Supervised exercise 9.22 (5.84) [109] 8.77 (5.98) [97] − 0.48 − 0.47 (− 1.46, 0.52) 0.348
Standard therapy 7.36 (4.55) [114] 7.51 (5.48) [107] − 0.01
HOMA-IR Supervised exercise 3.41 (2.33) [109] 3.11 (2.19) [97] − 0.28 − 0.31 (− 0.73, 0.10) 0.138
Standard therapy 2.74 (1.71) [114] 2.84 (1.98) [107] 0.04
HOMA-β Supervised exercise 42.04 (27.02) [109] 42.52 (30.84) [97] 0.73 2.39 (− 2.90, 7.68) 0.373
Standard therapy 33.41 (24.88) [114] 32.55 (30.75) [107] − 1.66
Triglycerides, mg/dL Supervised exercise 165.8 (134.9) [110] 154.8 (117.4) [97] − 12.4 − 6.9 (− 28.2, 14.4) 0.523
Standard therapy 154.6 (118.5) [114] 148.5 (107.0) [108] − 5.5
LDL-cholesterol, mg/dL Supervised exercise 124.9 (31.1) [110] 127.8 (32.5) [97] 2.0 0.9 (− 4.1, 5.9) 0.715
Standard therapy 128.1 (34.8) [114] 127.4 (30.8) [108] 1.0
HDL-cholesterol, mg/dL Supervised exercise 55.6 (16.0) [110] 57.5 (15.8) [97] 1.7 2.6 (0.8, 4.4) 0.004
Standard therapy 58.5 (13.8) [114] 57.6 (12.9) [108] –0.9
Systolic BP, mmHg Supervised exercise 126.2 (11.8) [110] 124.9 (13.9) [97] − 0.8 1.2 (− 1.7, 4.1) 0.407
Standard therapy 126.0 (14.2) [114] 123.6 (11.6) [108] − 2.0
Diastolic BP, mmHg Supervised exercise 78.1 (10.5) [110] 76.1 (10.6) [97] − 2.0 − 0.5 (− 2.5, 1.4) 0.587
Standard therapy 78.1 (10.4) [114] 76.3 (10.9) [108] − 1.5
Body weight, kg Supervised exercise 73.15 (12.64) [110] 73.44 (12.84) [97] − 0.42 − 0.31 (− 0.77, 0.15) 0.188
Standard therapy 71.88 (12.37) [114] 71.58 (12.46) [108] − 0.11
Waist circumference, cm Supervised exercise 92.25 (9.47) [110] 91.69 (9.01) [97] − 1.01 − 0.91 (− 1.87, 0.06) 0.066
Standard therapy 92.35 (9.70) [114] 92.01 (9.90) [108] − 0.10

BP blood pressure, CI confidence interval, FAS full analysis set, FBG fasting blood glucose, HDL high-density lipoprotein, HOMA-IR homeostatic model assessment for insulin resistance, HOMA-β homeostatic model assessment for beta-cell function, LDL low-density lipoprotein, LS least squares, MMRM mixed-model repeated measures, SD standard deviation

aMMRM with an unstructured covariance matrix within patients was used. The differences between groups were estimated using MMRM with 2-sided 95% CIs. Significance level: 0.05 (2-sided)

bEstimated difference between supervised exercise and standard therapy groups