Department of Pedodontics and Preventive Dentistry, Institute of Dental Sciences, Siksha O Anusandhan (Deemed to be University), Bhubaneshwar, 751030, Odisha, India.
BMC Endocr Disord. 2023 Sep 7;23(1):190. doi: 10.1186/s12902-023-01442-y.
Prediabetes and diabetes involve alterations in glucose homeostasis, including increased fasting blood glucose and impaired glucose tolerance. Berberine has been identified as a potential regulator of glucose homeostasis with implications on the management of type 2 diabetes mellitus (DM). Given a paucity of data on berberine in prediabetes, evaluation of its effect in individuals with prediabetes may prove clinically valuable.
The present pilot study aimed to investigate the effect of daily oral berberine on markers of glycemic control and insulin resistance among individuals with prediabetes.
A randomized, double-blinded, placebo-controlled trial was conducted for 12 weeks among 34 individuals with prediabetes as defined by the American Diabetes Association (fasting plasma glucose (FPG) between 5.6 and 6.9 mmol/L, glycosylated hemoglobin (HbA) between 5.7% and 6.4%, or 2-hour 75-gram oral glucose tolerance test (2 h-OGTT) between 7.8 and 11.1 mmol/L). HIMABERB® 500 mg was given three times daily to the treatment group, and placebo was administered three times daily to the control group. Glycemic control markers and physical parameters were evaluated for both groups on days 0, 28, 56, and 84. The glycemic control markers assessed included FPG, fasting insulin (FI), 2 h-OGTT, HbA, and homeostatic model assessment-insulin resistance (HOMA-IR). The observed outcomes were analyzed using independent t-test statistics to determine the significance of differences over time after treatment initiation and between treatment and control groups.
Significant decreases in all markers of glycemic control were observed in the treatment group at intermediate time points and the endpoint of the study compared to baseline levels and to the control group. For the treatment group, FPG decreased from 6.75 ± 0.23 mmol/L to 5.33 ± 0.28 mmol/L, FI from 9.81 ± 0.36 to 7.88 ± 0.52 mmol/L, 2 h-OGTT from 10.44 ± 0.52 to 8.12 ± 0.40 mmol/L, HbA from 6.40% ± 0.20-5.43% ± 0.21%, and HOMA-IR from 3.61 ± 0.31 to 2.41 ± 0.14. The decreases in glycemic control markers compared to the control group were clinically and statistically significant (p<10). No severe adverse effects, kidney or liver toxicity were detected.
After 12 weeks, berberine (HIMABERB®) intervention in individuals with prediabetes significantly reduced glycemic control markers, with mean FPG and 2 h-OTGG being reduced to below prediabetic thresholds, supporting the investigation of the use of HIMABERB® for delaying progression to diabetes mellitus.
http://ctri.nic.in (CTRI/2021/12/038751) (20/12/2021).
糖尿病前期和糖尿病涉及葡萄糖稳态的改变，包括空腹血糖升高和葡萄糖耐量受损。小檗碱已被确定为调节葡萄糖稳态的潜在调节剂，对 2 型糖尿病的管理有影响。鉴于糖尿病前期小檗碱的数据有限，评估其在糖尿病前期个体中的作用可能具有临床价值。
本初步研究旨在探讨每日口服小檗碱对糖尿病前期个体血糖控制和胰岛素抵抗标志物的影响。
34 名糖尿病前期患者（美国糖尿病协会定义为空腹血糖（FPG）为 5.6 至 6.9mmol/L、糖化血红蛋白（HbA）为 5.7%至 6.4%或 2 小时 75 克口服葡萄糖耐量试验（2 h-OGTT）为 7.8 至 11.1mmol/L）进行了为期 12 周的随机、双盲、安慰剂对照试验。治疗组每天服用 HIMABERB®500mg 三次，对照组每天服用安慰剂三次。在第 0、28、56 和 84 天评估两组的血糖控制标志物和身体参数。评估的血糖控制标志物包括 FPG、空腹胰岛素（FI）、2 h-OGTT、HbA 和稳态模型评估-胰岛素抵抗（HOMA-IR）。使用独立 t 检验统计分析观察到的结果，以确定治疗开始后和治疗组与对照组之间随时间的差异的显著性。
与基线水平和对照组相比，治疗组在中间时间点和研究终点时所有血糖控制标志物均显著降低。对于治疗组，FPG 从 6.75±0.23mmol/L 降至 5.33±0.28mmol/L，FI 从 9.81±0.36mmol/L 降至 7.88±0.52mmol/L，2 h-OGTT 从 10.44±0.52mmol/L 降至 8.12±0.40mmol/L，HbA 从 6.40%±0.20%降至 5.43%±0.21%，HOMA-IR 从 3.61±0.31mmol/L 降至 2.41±0.14mmol/L。与对照组相比，血糖控制标志物的降低具有临床和统计学意义（p<10）。未检测到严重不良事件、肾或肝毒性。
12 周后，糖尿病前期患者小檗碱（HIMABERB®）干预显著降低血糖控制标志物，平均 FPG 和 2 h-OTGG 降至糖尿病前期阈值以下，支持使用 HIMABERB®延缓糖尿病进展的研究。
http://ctri.nic.in（CTRI/2021/12/038751）（2021 年 12 月 20 日）。
