Background
Methods
Study population
Protocol
Endothelial function
Biochemical analysis
Evaluation of relevant factors
Statistical analysis
Results
Baseline characteristics
Variables | Vilda | High met |
p value |
---|---|---|---|
(n = 48) | (n = 48) | ||
Age (years) | 62 (31 to 74) | 60 (20 to 74) | 0.50* |
Male sex (%) | 54.2 | 64.6 | 0.43 |
Body mass index (kg/m2) | 25.7 ± 4.1 | 26.1 ± 4.7 | 0.59 |
Flow mediated dilatation (%) | 5.5 ± 2.0 | 6.1 ± 3.0 | 0.20 |
FPG (mM/L) | 7.8 ± 1.3 | 8.1 ± 1.3 | 0.20 |
Hemoglobin A1c (%) | 7.3 (6.6 to 8.4) | 7.2 (6.4 to 8.7) | 0.23* |
SBP (mmHg) | 129.0 ± 13.0 | 126.6 ± 12.2 | 0.35 |
DBP (mmHg) | 75.0 ± 9.2 | 75.5 ± 10.2 | 0.83 |
LDL-cholesterol (mg/dL) | 112.4 ± 30.0 | 110.6 ± 28.7 | 0.76 |
Current smokers (%) | 29.2 | 27.1 | 0.90 |
Hypertension (%) | 41.7 | 43.8 | 0.89 |
Dyslipidemia (%) | 77.1 | 68.8 | 0.43 |
Angiotensin-converting enzyme inhibitors/angiotensin II receptor blockers (%) | 31.3 | 27.1 | 0.81 |
Statin (%) | 39.6 | 35.4 | 0.80 |
Diabetic nephropathy (%) | 20.8 | 20.8 | 1.00 |
Metformin (mg) | 559.5 ± 107.8 | 595.2 ± 122.9 | 0.16 |
Sulfonylureas (%) | 18.8 | 27.1 | 0.65 |
Glinides (%) | 0 | 0 | 1.00 |
Endothelial function and atherosclerosis
Vilda (n = 48) | High met (n = 48) |
p value | |
---|---|---|---|
Baseline FMD (%) | 5.48 ± 2.03 | 6.14 ± 2.99 | |
12 weeks FMD (%) | 5.14 ± 2.27 | 5.39 ± 2.29 | |
ΔFMD (%) | − 0.51 (− 1.08 to 0.06) | − 0.58 (− 1.20 to 0.04) | |
Comparison of ΔFMD in ANCOVA | 0.08 (− 0.74 to 0.89) | reference | 0.854 |
Variables | R |
p value for the Spearman’s rank-correction | R |
p value for the Spearman’s rank-correction |
---|---|---|---|---|
Medication | Vilda | High met | ||
BMI | 0.038 | 0.803 | 0.013 | 0.932 |
HbA1c | − 0.131 | 0.386 | − 0.053 | 0.735 |
cSBP | − 0.069 | 0.651 | 0.050 | 0.751 |
Proinsulin/IRI ratio | − 0.060 | 0.694 | − 0.046 | 0.770 |
LDL-cholesterol | − 0.249 | 0.095 | 0.101 | 0.521 |
ApoB/ApoA1 ratio | − 0.326 | 0.026 | − 0.069 | 0.659 |
Adiponectin | 0.049 | 0.746 | 0.124 | 0.432 |
Variables | Vilda (n = 46) | High met (n = 43) |
p value | ||
---|---|---|---|---|---|
Baseline | After 12 weeks | Baseline | After 12 weeks | ||
BMI (kg/m2) | 25.8 ± 4.1 | 25.6 ± 4.3 | 25.8 ± 4.6 | 25.4 ± 4.6** | 0.25 |
SBP (mmHg) | 127.5 ± 11.3 | 126.4 ± 9.9 | 127.2 ± 12.5 | 127.8 ± 11.1 | 0.51 |
DBP (mmHg) | 74.7 ± 9.1 | 73.1 ± 8.2 | 76.0 ± 10.6 | 75.8 ± 9.4 | 0.51 |
Cardiovascular functions | |||||
cSBP (mmHg)a
| 138.2 ± 17.2 | 134.0 ± 16.5** | 136.8 ± 20.3 | 131.0 ± 16.7** | 0.52 |
Augmentation index (%) | 26.5 (− 38.0 to 88.0) | 24.0 (− 19.0 to 69.0) | 17.0 (− 9.0 to 68.0) | 20.0 (− 12.0 to 57.0) | 0.83 |
RHIa
| 1.74 (1.16 to 3.52) | 1.77 (1.15 to 4.32) | 1.73 (0.86 to 3.16) | 1.73 (0.95 to 3.99) | 0.37 |
Biochemical parameters | |||||
FPG (mM/L) | 7.8 ± 1.3 | 6.6 ± 0.9** | 8.0 ± 1.2 | 7.2 ± 1.0** | 0.09 |
Hemoglobin A1c (%) | 7.25 (6.60 to 8.40) | 6.45 (5.70 to 7.20)** | 7.20 (6.40 to 8.70) | 6.80 (6.00 to 8.20)** | < 0.01 |
IRI (µU/mL) | 5.8 (1.1 to 17.3) | 6.1 (1.3 to 21.5) | 5.0 (1.0 to 18.8) | 5.1 (1.0 to 16.7) | 0.92 |
Proinsulin/IRI ratio | 0.66 (0.19 to 2.12) | 0.50 (0.20 to 0.98)** | 0.63 (0.24-2.20) | 0.56 (0.07-2.04)** | 0.19 |
HOMA-IRa
| 1.88 (0.32 to 5.81) | 1.74 (0.33 to 6.00)* | 1.80 (0.28 to 9.19) | 1.64 (0.22 to 6.72) | 0.45 |
Glucagon (pg/mL) | 164 (114 to 337) | 155 (112 to 290) | 170 (105 to 325) | 158 (105 to 275)* | 0.73 |
LDL-cholesterol (mg/dL) | 107.9 (55.6 to 185.0) | 100.5 (42.2 to 160.4)* | 105.8 (53.2 to 180.2) | 99.2 (40 to 170.3)* | 0.64 |
HDL-cholesterol (mg/dL) | 52.0 (28.0 to 87.0) | 49.5 (28.0 to 85.0) | 55.0 (35.0 to 105.0) | 52.0 (35.0 to 98.0) | 0.75 |
Triglyceride (mg/dL) | 102.5 (46.0 to 289.0) | 106.0 (48.0 to 241.0) | 104.0 (27.0 to 369.0) | 102.0 (24.0 to 565.0) | 0.38 |
ApoA1 (mg/L) | 139 (95 to 227) | 142 (100 to 224) | 150 (103 to 224) | 146 (112 to 223) | 0.14 |
ApoB (mg/L) | 91 (49 to 148) | 87 (32 to 131)** | 92 (47 to 145) | 89 (52 to 146) | 0.06 |
ApoB/ApoA1 ratio | 0.66 (0.29 to 1.13) | 0.62 (0.21 to 1.29)** | 0.60 (0.31 to 1.13) | 0.60 (0.30 to 1.15) | 0.27 |
Adiponectin (µg/mL)a
| 6.25 (1.90 to 13.10) | 6.80 (1.90 to 15.50)** | 6.45 (1.60 to 16.90) | 5.90 (1.90 to 16.90) | < 0.01 |
NT-proBNP (pg/mL) | 31 (6 to 294) | 26 (6 to 414) | 26 (5 to 209) | 24 (5 to 169) | 0.27 |
TNF-α (pg/mL)b
| 1.10 (0.70 to 2.10) | 1.10 (0.60 to 2.40) | 1.25 (0.60 to 1.90) | 1.05 (0.60 to 2.10)* | 0.15 |
log hsCRP (ng/mL) | 2.88 ± 0.54 | 2.86 ± 0.54 | 2.74 ± 0.48 | 2.63 ± 0.48* | 0.19 |
log albuminuria (mg/g.Cre) | 1.04 (0.32 to 2.51) | 0.93 (0.41 to 2.67) | 0.98 (0.53 to 2.38) | 0.85 (0.45 to 2.59)* | 0.18 |
Oxidative stress | |||||
d-ROMs | 334.5 (230 to 525) | 344.0 (197 to 527) | 319 (205 to 488) | 318 (143 to 494) | 0.69 |
BAP | 2369 (1853 to 3085) | 2410 (1806 to 4201) | 2447 (1470 to 4622) | 2445 (1113 to 3676) | 0.30 |