Introduction
Research design and methods
Subjects
Ultrasound examination
Outcome measures
-
Mean GSM-CCA: the primary outcome of this study. The arithmetic average of the right and left GSM-CCA values. (If either the right or left GSM-CCA value was not obtained, the value of the other side was used as the mean GSM-CCA value).
-
Right GSM-CCA: the GSM value of the intima-media complex measured in the mean-IMT-CCA area (the segment 2 cm proximal to the dilation of the carotid bulb) of the right common carotid artery.
-
Left GSM-CCA: the GSM value of the intima-media complex measured in the mean-IMT-CCA area (the segment 2 cm proximal to the dilation of the carotid bulb) of the left common carotid artery.
-
Right GSM-plaque: the GSM value of the plaque lesion (max-IMT-CCA > 1.0 mm) with the greatest thickness measured in the right common carotid artery.
-
Left GSM-plaque: the GSM value of the plaque lesion (max-IMT-CCA > 1.0 mm) with the greatest thickness measured in the left common carotid artery.
Statistical analyses
Results
Baseline characteristics of study subjects
Effect of sitagliptin on metabolic factors and carotid IMT
Effect of sitagliptin on the ultrasonic tissue characteristics of the carotid wall
n | Sitagliptin treatment group | n | Conventional treatment group | Adj. mean difference (95% CI) | p value between-group | |
---|---|---|---|---|---|---|
Mean GSM-CCA (weeks) | ||||||
Baseline |
137
| 50.6 ± 18.6 |
136
| 52.6 ± 18.3 |
0.36
| |
52 |
130
| 51.1 ± 17.9 |
126
| 52.0 ± 17.6 |
0.66
| |
104 |
120
| 52.6 ± 16.9 |
122
| 53.5 ± 20.3 |
0.69
| |
Mean change (SE) (weeks) | ||||||
52 |
0.65 (1.11)
|
0.25 (1.14)
| 0.40 (− 2.74, 3.53) |
0.80
| ||
104 |
2.40 (1.19)*
|
1.32 (1.19)
| 1.08 (− 2.23, 4.39) |
0.52
| ||
Right GSM-CCA (weeks) | ||||||
Baseline | 136 | 51.3 ± 20.6 | 136 | 52.8 ± 18.9 | 0.53 | |
52 | 129 | 51.2 ± 19.1 | 126 | 53.1 ± 18.8 | 0.41 | |
104 | 120 | 53.2 ± 18.2 | 122 | 53.4 ± 20.6 | 0.94 | |
Mean change (SE) (weeks) | ||||||
52 | 0.14 (1.30) | 1.26 (1.32) | − 1.13 (− 4.77, 2.53) | 0.54 | ||
104 | 2.39 (1.38) | 0.85 (1.37) | 1.53 (− 2.30, 5.36) | 0.43 | ||
Left GSM-CCA (weeks) | ||||||
Baseline | 136 | 49.9 ± 19.9 | 136 | 52.5 ± 21.2 | 0.30 | |
52 | 130 | 50.9 ± 19.4 | 126 | 50.9 ± 19.5 | 0.99 | |
104 | 120 | 51.9 ± 19.0 | 122 | 53.6 ± 22.2 | 0.52 | |
Mean change (SE) (weeks) | ||||||
52 | 1.12 (1.38) | − 0.46 (1.40) | 1.58 (− 2.29, 5.45) | 0.42 | ||
104 | 2.08 (1.48) | 2.12 (1.48) | − 0.04 (− 4.17, 4.09) | 0.98 | ||
Right GSM-plaque (weeks) | ||||||
Baseline | 74 | 51.4 ± 19.5 | 65 | 55.8 ± 21.5 | 0.21 | |
52 | 72 | 51.7 ± 19.3 | 56 | 55.6 ± 22.9 | 0.30 | |
104 | 61 | 53.5 ± 20.4 | 62 | 59.2 ± 23.6 | 0.16 | |
Mean change (SE) (weeks) | ||||||
52 | 2.06 (2.04) | 2.80 (2.23) | − 0.74 (− 6.77, 5.28) | 0.81 | ||
104 | 5.49 (2.69)* | 4.20 (2.71) | 1.29 (− 6.30, 8.88) | 0.74 | ||
Left GSM-plaque (weeks) | ||||||
Baseline | 80 | 52.6 ± 23.5 | 77 | 55.4 ± 20.9 | 0.43 | |
52 | 76 | 51.2 ± 19.4 | 69 | 54.5 ± 20.5 | 0.32 | |
104 | 73 | 54.5 ± 21.3 | 73 | 51.9 ± 17.5 | 0.42 | |
Mean change (SE) (weeks) | ||||||
52 | 1.15 (2.19) | − 0.05 (2.24) | 1.20 (− 5.01, 7.41) | 0.70 | ||
104 | 5.10 (2.50)* | − 0.35 (2.57) | 5.45 (− 1.66, 12.56) | 0.13 |