Table 3. Clinical variables, glucose concentration and insulin parameters.
Variable | Baseline | Final | Change at 12 weeks relative to baseline | Treatment difference | ||
Mean±SD | Mean±SD | Adjusted least square mean [95%CI] (% change from baseline) | Adjusted least square mean [95%CI] (% difference from placebo) | P | ||
Clinical Parameters | ||||||
BMI (Kg/m2) | Placebo | 27.97±8.661 | 26.72±3.76 | -0.15 [-1.47; 1.16] (-0.54%) | -1.38 [-2.66; -0.10] (-5.5%) | 0.034 |
Intervention2 | 25.36±4.07 | 24.61±3.44 | -1.53 [-2.96; -0.11] (-6.03%) | |||
Weight (Kg) | Placebo | 72.01 ± 15.51 | 72.01 ± 15.51 | -0.14 [-1.00; 0.71] (-0.19%) | -0.93 [-1.74; -0.12] (-1.37%) | 0.025 |
Intervention | 68.81 ± 12.62 | 66.92 ± 11.63 | -1.08 [-1.99; -0.16] (-1.56%) | |||
Waist circumference (cm) | Placebo | 90.40±11.56 | 90.39±11.16 | 0.65[-1.36; 2.66] (0.72%) | 0.30 [-1.62; 2.23] (0.39%) | 0.754 |
Intervention | 86.20±11.76 | 86.24±10.76 | 0.96 [-1.17; 3.08] (1.11%) | |||
Systolic blood pressure (mmHg) | Placebo | 123.77±17.64 | 121.25±17.18 | |||
Intervention | 122.22±18.14 | 122.13±17.62 | ||||
Diastolic blood pressure (mmHg) | Placebo | 76.75±11.18 | 75.87±9.96 | |||
Intervention | 76.49±12.20 | 76.45±10.56 | ||||
Heart rate (bpm) | Placebo | 70.29±10.09 | 69.22±9.73 | |||
Intervention | 71.43±9.89 | 70.38±9.40 | ||||
Glucose and Insulin | ||||||
Glucose (mg/dL) | Placebo | 92.77±10.30 | 92.78±10.50 | -1.79 [-5.70; 2.12] (-1.93%) | -1.24 [-4.83; 2.35] (-1.42%) | 0.493 |
Intervention | 90.58±9.27 | 90.27±10.12 | -3.03 [-7.10; 1.03] (-3.35%) | |||
Insulin (pmol/L) | Placebo | 51.75±37.66 | 55.57±50.69 | 1.20 [-12.57; 14.97] (2.32%) | -6.53[-23.54; 10.47] (-11.72%) | 0.447 |
Intervention | 56.68±63.68 | 50.46±35.11 | -5.33 [-19.20; 8.55] (-9.40%) | |||
HOMA-IR | Placebo | 1.66±1.26 | 1.83±1.88 | 0.1 [-0.40; 0.59] (6.02%) | -0.30 [-0.91; 0.31] (-16.89%) | 0.333 |
Intervention | 1.84±2.56 | 1.58±1.14 | -0.20 [-0.70; 0.30] (-10.87%) |
Data calculated on the intention-to-treat population (n = 51). Results from the ANCOVA model; 2Intervention = AP = Armolipid Plus.