Table 3.
Mean change at 6th months from baseline in clinical data
| |
Intervention |
Control |
Model 1 (crude) |
Model 2 (adjusted) |
Model 3 (adjusted) |
Model 4 (adjusted) |
||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Mean | ± | SE | Mean | ± | SE | Difference | 95%CI | p-value | Difference | 95%CI | p-value | Differences | 95%CI | p-value | Difference | 95%CI | p-value | |
| HbA1c(%)# |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−0.7 |
± |
0.1 |
−0.2 |
± |
0.1 |
−0.5 |
(−0.8 to −0.2) |
0.004 |
−0.5 |
(−0.8 to −0.2) |
0.004 |
−0.5 |
(−0.8 to −0.2) |
0.003 |
−0.5 |
(−0.9 to −0.1) |
0.011 |
| CDS2) |
−0.7 |
± |
0.1 |
−0.2 |
± |
0.1 |
−0.5 |
(−0.9 to −0.1) |
0.009 |
−0.4 |
(−0.8 to −0.1) |
0.014 |
−0.5 |
(−0.1 to −0.8) |
0.013 |
−0.5 |
(−1.0 to −0.1) |
0.028 |
| MI3) |
−0.7 |
± |
0.1 |
−0.3 |
± |
0.1 |
−0.5 |
(−0.9 to −0.1) |
0.030 |
−0.4 |
(−0.8 to −0.1) |
0.041 |
−0.4 |
(−0.8 to −0.2) |
0.045 |
−0.4 |
(−0.6to −0.0) |
0.045 |
| BMI(kg/m2) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−0.5 |
± |
0.1 |
−0.3 |
± |
0.2 |
−0.2 |
(−0.7 to 0.2) |
0.351 |
−0.1 |
(−0.6 to 0.4) |
0.598 |
−0.1 |
(−0.6 to 0.3) |
0.548 |
−0.3 |
(−0.8 to 0.2) |
0.221 |
| CDS2) |
−0.6 |
± |
0.2 |
−0.3 |
± |
0.2 |
−0.3 |
(−0.8 to 0.1) |
0.146 |
−0.2 |
(−0.8 to 0.3) |
0.331 |
−0.3 |
(−0.8 to 0.3) |
0.297 |
−0.3 |
(−0.9 to 0.2) |
0.216 |
| MI3) |
−0.5 |
± |
0.1 |
−0.3 |
± |
0.2 |
−0.2 |
(−0.7 to 0.2) |
0.351 |
−0.1 |
(−0.7 to 0.5) |
0.693 |
−0.1 |
(−0.7 to 0.4) |
0.633 |
−0.1 |
(−0.6 to 0.5) |
0.829 |
| FPG(mg/dl) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−19 |
± |
8 |
−20 |
± |
8 |
1 |
(−23 to 25) |
0.919 |
8 |
(−11 to 28) |
0.367 |
9 |
(−11 to 29) |
0.347 |
22 |
(−10 to 54) |
0.165 |
| CDS2) |
−20 |
±10 |
10 |
−14 |
± |
11 |
7 |
(−37 to 23) |
0.633 |
1 |
(−23 to 25) |
0.933 |
0 |
(−25 to 25) |
0.993 |
5 |
(−33 to 43) |
0.792 |
| MI3) $ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| SBP(mmHg) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−1 |
± |
3 |
0 |
± |
3 |
1 |
(−9 to 7) |
0.748 |
−1 |
(−7 to 6) |
0.802 |
0 |
(−7 to 6) |
0.963 |
0 |
(−8 to 8) |
0.951 |
| CDS2) |
−1 |
± |
3 |
−2 |
± |
3 |
1 |
(−7 to 9) |
0.804 |
2 |
(−5 to 9) |
0.514 |
4 |
(−4 to 9) |
0.416 |
4 |
(−5 to 12) |
0.370 |
| MI3) |
−1 |
± |
3 |
−2 |
± |
3 |
−1 |
(−9 to 7) |
0.738 |
−2 |
(−8 to 5) |
0.593 |
−2 |
(−9 to 5) |
0.523 |
−3 |
(−11 to 4) |
0.368 |
| DBP(mmHg) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−1 |
± |
1 |
−3 |
± |
2 |
1 |
(−3 to 6) |
0.560 |
−3 |
(−1 to 7) |
0.164 |
−2 |
(−2 to 6) |
0.239 |
4 |
(−1 to 8) |
0.088 |
| CDS2) |
−0 |
± |
1 |
−4 |
± |
1 |
3 |
(−1 to 7) |
0.159 |
4 |
(−0 to 8) |
0.050 |
4 |
(−0 to 8) |
0.073 |
5 |
(0 to 10) |
0.049 |
| MI3) |
−1 |
± |
1 |
−3 |
± |
2 |
−2 |
(−7 to 2) |
0.296 |
−3 |
(−8 to 1) |
0.120 |
−3 |
(−8 to 1) |
0.166 |
−3 |
(−8 to 2) |
0.171 |
| LDL(mg/dl) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−5 |
± |
2 |
−1 |
± |
2 |
−4 |
(−10 to 3) |
0.286 |
−2 |
( −8 to 3) |
0.387 |
−3 |
(−10 to 3) |
0.245 |
−4 |
(−13 to 5) |
0.344 |
| CDS2) |
−4 |
± |
2 |
0 |
± |
3 |
−4 |
(−12 to 3) |
0.241 |
−3 |
(−10 to 4) |
0.371 |
−4 |
(−11 to 3) |
0.252 |
−5 |
(−16 to 5) |
0.283 |
| MI3) |
−5 |
± |
4 |
2 |
± |
4 |
7 |
( 2 to 12) |
0.198 |
6 |
( 0 to 10) |
0.250 |
7 |
(−4 to 17) |
0.196 |
7 |
(−6 to 18) |
0.223 |
| HDL(mg/dl) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−1 |
± |
1 |
1 |
± |
1 |
−0 |
(−4 to 3) |
0.823 |
−0 |
(−4 to 3) |
0.863 |
0 |
(−3 to 4) |
0.861 |
2 |
(−3 to 8) |
0.393 |
| CDS2) |
1 |
± |
2 |
2 |
± |
2 |
−1 |
(−6 to 4) |
0.745 |
−1 |
(−6 to 4) |
0.701 |
0 |
(−5 to 5) |
0.994 |
2 |
(−3 to 8) |
0.393 |
| MI3) $ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| Triglycerides(mg/dl) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
| LOCF1) |
−3 |
± |
8 |
−5 |
± |
9 |
2 |
(−23 to 26) |
0.894 |
4 |
(−20 to 28) |
0.748 |
2 |
(−22 to 27) |
0.239 |
7 |
(−28 to 43) |
0.667 |
| CDS2) |
−7 |
± |
8 |
−5 |
± |
9 |
−3 |
(−29 to 24) |
0.833 |
4 |
(−27 to 25) |
0.951 |
−5 |
(−31 to 22) |
0.708 |
−1 |
(−38 to 36) |
0.953 |
| MI3) $ | ||||||||||||||||||
SE: standard error, 95%CI: 95% confidence interval, degree of freedom = 18.
# Value of HbA1C is JDS15.
1) LOCF: last observation carried forward (IG: n = 100, CG: n = 93).
2) CDS: complete data set. (IG: n = 84), CG: n = 70).
3) MI: Multiple imputation with all analysed variables (number of imputations = 200) (IG: n = 100, CG: n = 93).
Model 1: crude.
Model 2: mixed model adjusted for baseline.
Model 3: mixed model adjusted for baseline, gender, age and BMI.
Model 4: mixed model adjusted for baseline, gender, age, BMI, smoking status, exercise status, change of exercise level, family history of type 2 diabetes, and complication.
$ The MI models did not converge.