Table 1.
Effect of metformin and fenofibrate, administered alone or in sequence, together with lifestyle intervention on lipid profile, glucose metabolism, low-grade inflammation, hemostasis, and cytokine secretion by stimulated monocytes in type 2 diabetic patients with mixed dyslipidemia
| Type 2 diabetic patients with mixed dyslipidemia complying with lifestyle intervention |
Patients not complying with lifestyle intervention |
|||||
|---|---|---|---|---|---|---|
| Placebo + placebo | Metformin + placebo | Placebo + fenofibrate | Metformin + fenofibrate | Diabetic dyslipidemia‖ | Control subjects¶ | |
| Number of patients | 30 | 31 | 30 | 33 | 32 | 32 |
| Fasting glucose (mg/dl) | ||||||
| Baseline | 169.1 ± 4.4*** | 168.8 ± 4.1*** | 164.5 ± 3.1*** | 165.9 ± 3.2*** | 165.8 ± 4.6*** | 90.1 ± 2.2 |
| After 30 days | 141.0 ± 5.6***†† | 121.8 ± 4.9***††† | 139.4 ± 3.6***† | 120.5 ± 3.1***††† | 162.2 ± 4.0*** | 90.5 ± 2.0 |
| After 60 days | 147.5 ± 3.9***† | 109.6 ± 4.3***†††‡ | 142.1 ± 3.2***† | 106.1 ± 3.7*†††‡ | 167.2 ± 3.8*** | 88.2 ± 1.9 |
| HOMA | ||||||
| Baseline | 11.5 ± 0.7*** | 11.7 ± 0.6*** | 11.3 ± 0.8*** | 11.9 ± 0.7*** | 11.4 ± 0.8*** | 2.1 ± 0.2 |
| After 30 days | 11.1 ± 0.6*** | 8.0 ± 0.6***† | 10.9 ± 0.5*** | 8.9 ± 0.8***† | 11.6 ± 0.6*** | 2.0 ± 0.1 |
| After 60 days | 10.3 ± 0.5***† | 6.8 ± 0.4***††† | 8.7 ± 0.6***††‡ | 5.0 ± 0.4**†††‡‡‡ | 11.3 ± 0.9*** | 2.2 ± 0.2 |
| A1C (%) | ||||||
| Baseline | 7.5 ± 0.2*** | 7.4 ± 0.2*** | 7.5 ± 0.2*** | 7.4 ± 0.1*** | 7.4 ± 0.3*** | 5.1 ± 0.2 |
| After 30 days | 7.0 ± 0.2***† | 6.5 ± 0.2***†† | 7.0 ± 0.2***† | 6.5 ± 0.2***†† | 7.4 ± 0.2*** | 5.0 ± 0.1 |
| After 60 days | 7.0 ± 0.2***† | 6.2 ± 0.1***††† | 6.7 ± 0.2***†† | 6.1 ± 0.1**††† | 7.3 ± 0.2*** | 5.1 ± 0.2 |
| Total cholesterol (mg/dl) | ||||||
| Baseline | 226.5 ± 4.1*** | 229.3 ± 3.2*** | 228.1 ± 4.2*** | 232.1 ± 3.6*** | 228.8 ± 5.4*** | 162.0 ± 4.2 |
| After 30 days | 224.4 ± 4.2*** | 228.3 ± 2.5*** | 216.6 ± 3.2*** | 221.1 ± 3.5*** | 230.1 ± 3.4*** | 160.0 ± 3.2 |
| After 60 days | 229.3 ± 5.0*** | 223.6 ± 4.0*** | 188.3* ± 4.5**††‡ | 183.8 ± 4.0*†††‡‡ | 231.1 ± 2.3*** | 159.9 ± 2.3 |
| LDL cholesterol (mg/dl) | ||||||
| Baseline | 148.2 ± 2.3*** | 150.3 ± 2.6*** | 149.0 ± 3.2*** | 150.6 ± 2.6*** | 151.1 ± 3.5*** | 108.1 ± 2.8 |
| After 30 days | 148.1 ± 2.4*** | 147.0 ± 3.1*** | 139.8 ± 4.1*** | 142.2 ± 2.0*** | 147.4 ± 2.8*** | 110.4 ± 2.6 |
| After 60 days | 145.0 ± 3.0*** | 140.9 ± 3.5*** | 115.1 ± 3.2†††‡ | 113.4 ± 1.9†††‡‡ | 145.4 ± 3.7*** | 110.7 ± 2.7 |
| HDL cholesterol (mg/dl) | ||||||
| Baseline | 40.1 ± 1.0*** | 39.5 ± 1.1*** | 40.4 ± 1.1*** | 39.2 ± 1.0*** | 39.9 ± 1.1*** | 47.8 ± 0.7 |
| After 30 days | 41.8 ± 0.7*** | 40.1 ± 0.3*** | 40.6 ± 0.6*** | 41.5 ± 0.4** | 39.0 ± 1.3*** | 48.0 ± 0.6 |
| After 60 days | 42.1 ± 0.6*** | 41.0 ± 0.3*** | 43.2 ± 0.5**†† | 43.7 ± 0.3*†† | 39.2 ± 0.6*** | 47.1 ± 0.5 |
| Triglycerides (mg/dl) | ||||||
| Baseline | 206.8 ± 6.4*** | 219.6 ± 5.2*** | 214.8 ± 6.8*** | 215.9 ± 5.5*** | 214.4 ± 8.8*** | 122.4 ± 3.2 |
| After 30 days | 193.8 ± 6.8*** | 198.6 ± 5.1*** | 204.8 ± 5.3*** | 190.6 ± 4.5*** | 212.5 ± 8.0*** | 121.1 ± 4.0 |
| After 60 days | 181.5 ± 8.2***† | 184.5 ± 6.0***† | 166.8 ± 7.8**††† | 142.2 ± 8.2††† | 210.0 ± 7.8*** | 120.4 ± 4.6 |
| hsCRP (mg/l) | ||||||
| Baseline | 3.0 ± 0.2*** | 2.9 ± 0.2*** | 2.8 ± 0.2*** | 2.9 ± 0.2*** | 2.8 ± 0.1*** | 1.0 ± 0.1 |
| After 30 days | 2.8 ± 0.3*** | 2.5 ± 0.2*** | 2.5 ± 0.2*** | 2.7 ± 0.2*** | 2.8 ± 0.2*** | 1.0 ± 0.2 |
| After 60 days | 2.8 ± 0.3*** | 2.2 ± 0.1***† | 1.9 ± 0.4***† | 2.0 ± 0.2***††‡ | 2.7 ± 0.2*** | 1.1 ± 0.1 |
| Fibrinogen (mg/dl) | ||||||
| Baseline | 455.0 ± 48.1*** | 474.1 ± 32.9*** | 453.5 ± 37.6*** | 469.9 ± 18.3*** | 474.2 ± 32.1*** | 296.5 ± 22.0 |
| After 30 days | 467.8 ± 45.1*** | 440.2 ± 49.0*** | 465.1 ± 35.4*** | 443.1 ± 54.2*** | 486.0 ± 21.0*** | 285.1 ± 23.4 |
| After 60 days | 460.5 ± 51.6*** | 436.4 ± 29.5*** | 391.2 ± 36.7***†‡ | 346.3 ± 48.9*††‡ | 475.1 ± 27.5*** | 290.3 ± 19.8 |
| PAI-1 (ng/ml) | ||||||
| Baseline | 101.5 ± 4.1*** | 99.4 ± 3.9*** | 102.0 ± 4.8*** | 95.7 ± 3.6*** | 101.1 ± 5.2*** | 49.6 ± 6.2 |
| After 30 days | 100.6 ± 6.1*** | 94.8 ± 3.8*** | 94.8 ± 5.1*** | 92.0 ± 2.7*** | 102.4 ± 4.4*** | 48.1 ± 4.2 |
| After 60 days | 103.3 ± 5.7*** | 92.1 ± 4.0*** | 73.9 ± 4.6***††‡ | 69.8 ± 4.5**†††‡ | 100.8 ± 4.6*** | 48.9 ± 5.1 |
| TNF-α release (pg/ml) | ||||||
| Baseline | 1,530.0 ± 68.1*** | 1,453.5 ± 42.1*** | 1,511.2 ± 64.5*** | 1,449.8 ± 53.2*** | 1,489.1 ± 71.1*** | 901.7 ± 46.6 |
| After 30 days | 1,486.6 ± 70.8*** | 1,382.4 ± 35.1*** | 1,332.4 ± 53.2** | 1,028.9 ± 87.3*† | 1,523.1 ± 68.2*** | 895.3 ± 38.2 |
| After 60 days | 1,484.2 ± 56.7*** | 1,108.9 ± 52.0**† | 830.1 ± 69.0†† | 620.1 ± 35.9†††‡‡ | 1,510.8 ± 36.4*** | 908.2 ± 44.5 |
| Interleukin-1β release (pg/ml) | ||||||
| Baseline | 132.5 ± 5.2*** | 136.3 ± 6.8*** | 136.5 ± 7.0*** | 138.8 ± 7.1*** | 135.0 ± 4.0*** | 86.1 ± 6.5 |
| After 30 days | 146.8 ± 7.3*** | 139.0 ± 5.9*** | 125.8 ± 8.0** | 139.5 ± 6.4*** | 138.4 ± 3.9*** | 90.2 ± 5.4 |
| After 60 days | 145.2 ± 3.8*** | 126.8 ± 7.3*** | 90.3 ± 5.6†††‡‡ | 92.5 ± 7.0†††‡‡ | 130.1 ± 6.8*** | 87.5 ± 3.2 |
Data are means ± SEM.
*P < 0.05,
**P < 0.01,
***P < 0.001 vs. control subjects;
†P < 0.05,
††P < 0.01,
†††P < 0.001 vs. baseline values,
‡P < 0.05,
‡‡P < 0.01,
‡‡‡P < 0.001 vs. values after 30 days of treatment.
‖Type 2 diabetic patients with mixed dyslipidemia.
¶Subjects without carbohydrate and lipid abnormalities.