Serum total protein (TP) was measured by Biuret method (Dimension RXL, Dade Behring). Serum AGEs was expressed as a ratio of AGEs fluorescence intensity to total protein (AGEs/TP ratio). All analyses were performed in triplicates. Data analysis was carried out as per protocol (PP) principle. Data were OTX015 expressed as number of patients (N), mean ± SD or mean difference ± SE of difference. The differences between baseline and after intervention were expressed as change
values (Δ) at week 8 and week 16. Discrete data were evaluated by Pearson’s Chi-square or Fisher’s Exact test. Two factor repeated measures analysis of variance (RM-ANOVA) with multiple comparisons by Bonferroni or Friedman test were used to assessed the effects of treatment, time, and their interaction. Independent t-test or Mann–Whitney test was utilized in comparing the effect between 2 groups at each time point. Paired t-test or Wilcoxon Signed Rank test was applied to compare the change values after 8 weeks and
16 weeks of treatment within group. The 2-sided hypothesis was used in all tests and P < 0.05 was considered statistically significant. Thirty-eight T2DM patients were completely participated in this study. They were HER2 inhibitor randomized to continuously take either 6 g/day of dried-fruit powder of MC equivalent to 6.26 ± 0.28 mg of charantin (N = 19), or placebo (N = 19) for 16 weeks. All baseline characteristics at week 0 between the 2 groups did not differ ( Table 1). Mean dietary intake at the same period of the time was not different between groups, and all nutrient intakes of each group did not alter throughout the study ( Table 2). This indicated that food consumption of all patients was maintained throughout the study. Percentage of ingested capsules did not differ between the MC and placebo groups (96.11 ± 3.07%
and 94.50 ± 3.11%, respectively) indicating that both groups had good compliance. None of patient was non-adherent which defined as failure to take assigned investigational product (less than 80% base upon capsule counting). Laboratory and physical assessments at baseline and mean change from baseline at week 8 and week 16 were shown in Table 3. All parameters at Carnitine palmitoyltransferase II baseline of the MC and placebo groups were not different. Body weight, body mass index (BMI) and blood pressure (BP) did not differ between groups and did not alter throughout the trial. The results showed that mean decrement of A1C was significantly different between the groups and between each time point of the intervention. After 8 weeks of the treatment, the mean reduction from baseline of A1C of the MC group (−0.27 ± 0.30%) was more than that of the placebo group (−0.02 ± 0.43%), and the mean difference was 0.25 ± 0.12% (P = 0.042). In addition, the mean decrement of A1C from baseline after consumption of MC for 16 weeks (−0.50 ± 0.45%) was significantly greater than that of the placebo group (−0.20 ± 0.45%), and the mean difference between them was 0.31 ± 0.15% (P = 0.044).
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