Table II.
Change of laboratory values at 6 months
| Parameter | Baseline | 6 months | % change | P-value vs. baseline | P-value between groups |
|---|---|---|---|---|---|
| HbA1c (%): | NS | ||||
| AA | 5.9 ±0.3 | 5.9 ±0.4 | – | NS | |
| Placebo | 5.9 ±0.3 | 5.9 ±0.3 | – | NS | |
| Fasting plasma glucose [mg/dl]: | NS | ||||
| AA | 105.4 ±8.7 | 104.2 ±11 | –1 | NS | |
| Placebo | 102.6 ±8 | 102.6 ±10 | – | NS | |
| Fasting plasma insulin [µU/ml]: | NS | ||||
| AA | 10.2 (4.3–13.2) | 9.4 (5.7–16.1) | –8 | NS | |
| Placebo | 14.0 (5.6–14.6) | 12.6 (6.7–17.8) | –10 | NS | |
| HOMA-IR index: | NS | ||||
| AA | 2.4 (1.1–3.5) | 2.1 (1.5–4.5) | –12 | NS | |
| Placebo | 2.5 (1.4–3.4) | 2.1 (1.2–4.3) | –16 | NS | |
| Total cholesterol [mg/dl]: | NS | ||||
| AA | 164 ±21 | 162 ±27 | –1 | NS | |
| Placebo | 165 ±26 | 169 ±30 | +2 | NS | |
| Triglycerides [mg/dl]: | NS | ||||
| AA | 122 ±51 | 111 ±45 | –9 | NS | |
| Placebo | 121 ±51 | 126 ±47 | +4 | NS | |
| High-density lipoprotein cholesterol [mg/dl]: | NS | ||||
| AA | 52 ±9 | 53 ±10 | +2 | NS | |
| Placebo | 49 ±11 | 48 ±10 | –2 | NS | |
| Low-density lipoprotein cholesterol [mg/dl]: | NS | ||||
| AA | 88 ±18 | 88 ±22 | – | NS | |
| Placebo | 93 ±21 | 96 ±25 | +3 | NS | |
AA – active agent, HbA1c – glycated hemoglobin c, HOMA-IR – homeostasis model assessment-insulin resistance, NS – non-significant. All variables are expressed as the mean ± standard deviation (SD) except for non-normally distributed variables, which are presented as the median (range).