Table 5.
General measurements and circulating safety parameters
|
V0 |
V2 |
V3 |
V4 |
|||||
|---|---|---|---|---|---|---|---|---|
| Variable | Mean | Std Dev | Mean | Std Dev | Mean | Std Dev | Mean | Std Dev |
| Biometry | ||||||||
| Weight, kg | 81.5 | 6.47 | 81.3 | 6.86 | 81.6 | 6.84 | 81.6 | 6.69 |
| Waist size, cm | 97.9 | 6.15 | 97.9 | 7.34 | 97.1 | 6.94 | 97.4 | 7.33 |
| BMI, kg·m–² | 27.6 | 1.85 | 27.5 | 1.97 | 27.5 | 2.05 | 27.6 | 1.99 |
| Vital parameters | ||||||||
| Systolic blood pressure, mmHg | 136 | 16.3 | 133 | 11.5 | 135 | 15.3 | 134 | 15.2 |
| Diastolic blood pressure, mmHg | 85.9 | 10.1 | 84.6 | 11.5 | 83.3 | 7.56 | 83.9 | 9.76 |
| Heat rate, beats/min | 63.2 | 13.8 | 62.9 | 13.7 | 64.0 | 11.5 | 62.8 | 12.9 |
| O2 saturation, % | 97.3 | 1.73 | 98.7 | 1.65 | 98.0 | 1.47 | 98.1 | 1.38 |
| PR interval, ms | 168 | 19.3 | 168 | 24.1 | 169 | 20.9 | 171 | 21.4 |
| QRS complex, ms | 88.1 | 5.40 | 89.4 | 6.01 | 90.6 | 6.45 | 88.5 | 5.61 |
| QT interval, ms | 399 | 39.1 | 400 | 28.9 | 405 | 34.5 | 395 | 26.6 |
| QTc interval, ms | 385 | 29.7 | 388 | 24.6 | 398 | 19.2 | 383 | 26.9 |
| QRS axis, ms | 26.1 | 29.6 | 24.1 | 27.4 | 26.9 | 29.5 | 24.2 | 29.3 |
| Blood analysis | ||||||||
| ALAT, UI/L | 40.9 | 13.4 | 38.2 | 13.2 | 36.6 | 14.5 | 39.0 | 10.8 |
| ALC. PHOSP, UI/L | 61.0 | 20.0 | 60.8 | 19.0 | 60.7 | 19.0 | 59.5 | 18.1 |
| ASAT, UI/L | 23.8 | 5.52 | 23.6 | 3.84 | 24.0 | 5.41 | 24.9 | 3.47 |
| Bilirubin, µmol·L–1 | 9.21 | 2.72 | 9.79 | 2.83 | 8.69 | 2.84 | 10.2 | 2.38 |
| Cholesterol HDL, mmol. mmol·L–1 | 1.43 | 0.40 | 1.48 | 0.46 | 1.41 | 0.38 | 1.41 | 0.36 |
| Cholesterol TOTAL, mmol·L–1 | 4.83 | 0.85 | 4.56 | 0.87 | 4.74 | 0.78 | 4.43aa | 0.81 |
| Cholesterol LDL, mmol·L–1 | 2.81 | 0.85 | 2.60a | 0.77 | 2.69 | 0.78 | 2.49aa,c | 0.71 |
| Creatinine, µmol·L–1 | 75.8 | 7.92 | 79.4 | 8.27 | 81.3aa | 9.99 | 76.7c | 9.02 |
| Fructosamine, µmol·L–1 | 216 | 13.9 | 220 | 11.1 | 214 | 15.5 | 205aa,cc | 15.5 |
| GGT, mUI/L | 47.3 | 31.9 | 45.8 | 34.1 | 44.1 | 34.1 | 51.7c | 35.2 |
| Glucose, mmol·L–1 | 4.71 | 0.41 | 4.83 | 0.50 | 4.59 | 0.38 | 4.82c | 0.56 |
| Insulin, mUI·L–1 | 8.08 | 6.51 | 9.76 | 9.08 | 9.90 | 10.2 | 10.9 | 8.35 |
| Oxidized LDL, % | 39.6 | 12.5 | 37.8 | 14.6 | 35.4 | 11.2a | 33.8 | 11.4 |
| Triglyceride, mmol·L–1 | 1.31 | 0.57 | 1.07a | 0.59 | 1.40 | 0.55 | 1.21 | 0.58 |
| Urea, mmol·L–1 | 5.74 | 1.40 | 5.98 | 1.43 | 6.31a | 1.74 | 6.19 | 1.42 |
| Urine analysis | ||||||||
| Urine Creatinine, µmol·L–1 | 17.6 | 6.57 | 16.5 | 6.67 | 17.6 | 6.45 | 17.5 | 4.87 |
Significant differences are shown in bold in the table. Two-way ANOVA (subject and visit) associated with post hoc calculation of probability based on MLS means. Different from V0: aP < 0.05; aaP < 0.01. Different from V3: cP < 0.05 mL; P < 0.01. No change was considered clinically relevant by the investigators. ALAT: alanine aminotransferase; ALC. PHOSP, alkaline phosphatase; ASAT, aspartate aminotransferase; BMI, body mass index; DIASTO BP, diastolic blood pressure; GGT, gamma-glutamyltranspeptidase; H. RATE, heart rate; QTc INTERVAL, corrected QT interval; SYSTO BP, systolic blood pressure. Values as means ± SD. n = 14 subjects for all measurements.