Department of Medicine-DIMED, University of Padova, I-35128 Padova, Italy.
Department of Pharmaceutical and Pharmacological Sciences, University of Padova, I-35131 Padova, Italy.
Nutrients. 2021 Jul 11;13(7):2373. doi: 10.3390/nu13072373.
The aim of the study was to evaluate the overall biohumoral and metabolic effects of a 12-week add-on therapy consisting of a new nutraceutical formulation (BHC) based on berberine, hesperidin, and chromium picolinate in type 2 diabetes mellitus (T2D) patients with suboptimal glycemic compensation receiving metformin. After 12 weeks, participants in the group receiving metformin plus BHC, compared to the group receiving metformin only, saw a significant improvement in their glucose profile, in terms of both glycated hemoglobin (HbA1c) and fasting blood glucose (FBG). Their FBG dropped from 145 ± 20 mg/dL to 128 ± 23 mg/dL ( < 0.01), a decrease of 11.7% compared with the baseline. This decrease differed significantly from the situation in the control arm ( < 0.05). HbA1c decreased by 7.5% from the baseline, from 53.5 ± 4.3 mmol/mol to 49.5 ± 5.1 mmol/mol ( < 0.01), in the group given BHC, while no difference was seen in the control group. Advanced glycation end products (AGEs) and malondialdehyde (MDA) were found to be significantly reduced ( < 0.01) only in the BHC group, from 9.34 ± 7.61 μg/mL to 6.75 ± 6.13 μg/mL, and from 1.7 ± 0.15 μmol/L to 1.4 ± 0.25 μmol/L, respectively. In patients with T2D taking metformin with suboptimal glycemic compensation, adding BHC for 3 months significantly improved glucose control in terms of FBG and HbA1c, and had a positive effect on the lipid peroxidation profile, as indicated by a decrease in AGEs and MDA.
本研究的目的是评估在接受二甲双胍治疗但血糖控制仍不理想的 2 型糖尿病（T2D）患者中，添加基于小檗碱、橙皮苷和吡啶甲酸铬的新型营养配方（BHC）进行为期 12 周的辅助治疗的整体生物体液和代谢效应。治疗 12 周后，与仅接受二甲双胍治疗的患者相比，接受二甲双胍加 BHC 治疗的患者血糖谱得到显著改善，糖化血红蛋白（HbA1c）和空腹血糖（FBG）均有所改善。他们的 FBG 从 145±20mg/dL 降至 128±23mg/dL（<0.01），与基线相比下降了 11.7%。这一降幅与对照组明显不同（<0.05）。HbA1c 从基线水平下降了 7.5%，从 53.5±4.3mmol/mol 降至 49.5±5.1mmol/mol（<0.01），而对照组则没有差异。仅在 BHC 组中，晚期糖基化终产物（AGEs）和丙二醛（MDA）显著降低（<0.01），分别从 9.34±7.61μg/mL 降至 6.75±6.13μg/mL，从 1.7±0.15μmol/L 降至 1.4±0.25μmol/L。对于接受二甲双胍治疗但血糖控制仍不理想的 T2D 患者，添加 BHC 治疗 3 个月可显著改善 FBG 和 HbA1c 控制血糖的效果，并对脂质过氧化谱产生积极影响，AGEs 和 MDA 减少。
