- 學位論文
隨機、雙盲、以安慰劑為對照之人體研究評估富含mcIRBP-19之苦瓜萃取物對第2型糖尿病患者輔助調節血糖之效益
A randomized, double-blind, placebo-controlled trial to evaluate the auxiliary hypoglycemic efficacy of mcIRBP-19-rich Momordica charantia extracts in type 2 diabetic subjects
摘要
本試驗研究目的是以隨機、雙盲、安慰劑為對照、平行比較之人體研究評估富含胰島素受器結合胜肽(Momordica charantia insulin receptor binding peptide; mcIRBP) -19之苦瓜胜肽萃取物(簡稱苦瓜胜肽)對於使用藥物治療未達目標之第2型糖尿病人是否具有調節血糖之效益。本研究於中山醫學大學附設醫院內分泌暨新陳代謝科門診進行收案，共進行12週，合計40名個案順利完成試驗，隨機分配為兩組:苦瓜胜肽添加治療組(N=20)及背景治療組(N=20)。受測者每天口服600 mg試驗品或安慰劑並於服用前後抽血檢查血糖、健康狀態、安全性等指標。結果顯示苦瓜胜肽添加治療組與背景治療組比較，可以增加空腹血糖及HbA1c的改善百分比。以Wilcoxon signed-rank配對比較食用前後的差異，結果顯示口服苦瓜胜肽一個月顯著降低空腹血糖 (P = 0.023)，口服三個月後顯著降低HbA1c (P = 0.001)，而背景治療組則不會(P > 0.05)。但部份的病人因藥物作用HbA1c仍穩定的下降，為了減少藥物的影響，我們進一步排除試驗前HbA1c持續下降受測者12名進行統計分析(N = 29)，結果顯示此次族群口服苦瓜胜肽具有更強的降低空腹血糖及HbA1c的作用。本研究結果證實補充富含mcIRBP-19苦瓜萃取物對口服藥物治療未達目標之第2型糖尿病患者具有調節血糖的效益，特別是對於試驗前HbA1c未持續下降的次族群，其效益更為顯著。此外，富含mcIRBP-19苦瓜萃取物亦可能具有防止糖尿病患者手臂圍及大腿圍降低、提升高密度脂蛋白膽固醇以及調節心率的作用。
並列摘要
The purpose of current study was to evaluate the hypoglycemic efficacy of peptide-rich Momordica charantia extracts rich in Momordica charantia insulin receptor binding peptide-19 (mcIRBP -19) (below abbreviate bitter melon peptide) in type 2 diabetic subjects who take antidiabetic medication but don’t achevive the treatment goal, using a randomized, double-blind, parallel, placebo-controlled human study. This study was performed at the department of Endocrinology and Metabolism in the Chung-shan Medical University hospital for 12 weeks. A total of 40 patients completed the trial and were randomly assigned to two groups: bitter melon peptide treatment group (N=20) and control group (N=20). Subjects were orally administered 600 mg test product or placebo daily. The blood was taken before and after the test to examine blood glucose, health status, and safety. The results showed that compared with the control group, the bitter melon peptide treatment group could increase the fasting blood glucose and the improvement percentage of HbA1c. Using wilcoxon signed-rank test compared before and after consumption, and the results showed that oral bitter melon peptide significantly reduced fasting blood glucose (P = 0.023) after one month of oral administration and significantly decreased HbA1c (P = 0.001) after three months of oral administration, while control group did not show any changes in fasting plasma glucose and HbA1c (P > 0.05). However, in some patients, HbA1c was still steadily declining due to medication action. To reduce the influence of the medication, we further excluded 12 subjects who continued to decline in HbA1c before the trial for statistical analysis (N = 29). The results showed that the subgroup in bitter melon peptide orally have a stronger effect on reducing fasting blood glucose and HbA1c. The results of this study confirm that supplementation of bitter melon peptide has the benefit of regulating blood glucose in patients with type 2 diabetes who have failed to achieve the treatment goals, especially for subgroup in which HbA1c did not consistently decline before the trial. In addition, the mcIRBP-19-enriched bitter melon extract may also have the effect of preventing the lowering of the arm circumference and thigh circumference of diabetic patients, raising the high-density lipoprotein cholesterol and regulating the heart rate.