一项多中心临床研究，旨在确定一种新型胡芦巴籽提取物（Fenfuro™）对2型糖尿病患者的疗效。
A multicenter clinical study to determine the efficacy of a novel fenugreek seed () extract (Fenfuro™) in patients with type 2 diabetes.
作者信息
Verma Narsingh, Usman Kauser, Patel Naresh, Jain Arvind, Dhakre Sudhir, Swaroop Anand, Bagchi Manashi, Kumar Pawan, Preuss Harry G, Bagchi Debasis
机构信息
Department of Physiology, King George's Medical University, Lucknow, India.
Department of Medicine, King George's Medical University, Lucknow, India.
出版信息
Food Nutr Res. 2016 Oct 11;60:32382. doi: 10.3402/fnr.v60.32382. eCollection 2016.
BACKGROUND
(fenugreek) seeds are known to exhibit potent antioxidant, hypoglycemic, and nephroprotective activities, as well as serve as excellent membrane stabilizers especially because of their content of novel furostanolic saponins. Our previous studies exhibited the broad spectrum safety and efficacy of Fenfuro, a novel seed extract enriched in furostanolic saponins, in type 2 diabetes (T2D) in rats.
DESIGN
This multicenter, randomized, placebo-controlled, double-blind, add-on clinical study evaluated over a period of 90 consecutive days the efficacy of Fenfuro (daily dosage: 500 mg bid) in 154 subjects (male: 108; female: 46; age: 25-60 years) with T2D.
METHODS
This study examined the body weight, blood pressure, and pulse rate, as well as the efficacy of Fenfuro on fasting and post-prandial plasma sugar (mg/dL), glycosylated hemoglobin (HbA1c), and fasting and post-prandial C-peptide levels.
RESULTS
Fenfuro caused significant reduction in both fasting plasma and post-prandial blood sugar levels. Approximately 83% of the subjects reported decreases in fasting plasma sugar levels in the Fenfuro-treated group as compared to 62% in the placebo group, while 89% of the subjects demonstrated reduction in post-prandial plasma sugar levels in the Fenfuro-treated group as compared to 72% in the placebo group. HbA1c levels were reduced in both placebo and treatment groups. The decrease in HbA1c levels was significant in both groups as compared to respective baseline values. A significant increase in fasting and post-prandial C-peptide levels compared to the respective baseline values was observed, while no significant changes in fasting and post-prandial C-peptide levels were observed between the two groups. No significant adverse effects were observed by blood chemistry analyses. Furthermore, 48.8% of the subjects reported reduced dosage of anti-diabetic therapy in the Fenfuro-treated group, whereas 18.05% reported reduced dosage of anti-diabetic therapy in the placebo group.
CONCLUSION
In summary, Fenfuro proved safe and efficacious in ameliorating the symptoms of T2D in humans.
背景
葫芦巴种子具有强大的抗氧化、降血糖和肾保护活性，并且由于其富含新型呋甾烷醇皂苷，是出色的膜稳定剂。我们之前的研究显示，新型富含呋甾烷醇皂苷的葫芦巴种子提取物Fenfuro在大鼠2型糖尿病（T2D）中具有广泛的安全性和有效性。
设计
这项多中心、随机、安慰剂对照、双盲、附加临床研究连续90天评估了Fenfuro（每日剂量：500毫克，每日两次）对154名T2D患者（男性：108名；女性：46名；年龄：25 - 60岁）的疗效。
方法
本研究检测了体重、血压和脉搏率，以及Fenfuro对空腹和餐后血糖（毫克/分升）、糖化血红蛋白（HbA1c）以及空腹和餐后C肽水平的疗效。
结果
Fenfuro使空腹血糖和餐后血糖水平均显著降低。与安慰剂组62%的受试者相比，Fenfuro治疗组约83%的受试者空腹血糖水平下降；与安慰剂组72%的受试者相比，Fenfuro治疗组89%的受试者餐后血糖水平下降。安慰剂组和治疗组的HbA1c水平均降低。与各自的基线值相比，两组HbA1c水平的下降均显著。与各自的基线值相比，空腹和餐后C肽水平显著升高，而两组之间空腹和餐后C肽水平未观察到显著变化。血液化学分析未观察到显著不良反应。此外，Fenfuro治疗组48.8%的受试者报告降糖治疗药物剂量减少，而安慰剂组为18.05%。
结论
总之，Fenfuro在改善人类T2D症状方面被证明是安全有效的。
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