Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
Department of Pharmacology, All India Institute of Medical Sciences, New Delhi, India.
Can J Diabetes. 2014 Dec;38(6):466-72. doi: 10.1016/j.jcjd.2014.01.006. Epub 2014 Jun 3.
Statins are commonly used for the management of dyslipidemia in type 2 diabetes mellitus patients. We hypothesized that atorvastatin could modulate the beta-cell function by altering the levels of proapoptotic and antiapoptotic lipoproteins and could also have an effect on insulin resistance. The aim of the present pilot study was to assess the effect of atorvastatin 10 mg on pancreatic beta-cell function and insulin resistance in patients with hyperlipidemia and type 2 diabetes by using the homeostasis model assessment-2 (HOMA2) index.
Fifty-one type 2 diabetes patients receiving oral antidiabetes drugs, not taking statins, with baseline low-density lipoprotein cholesterol between 2.6 mmol/L and 4.1 mmol/L were included. Forty-three patients (21 in placebo group and 22 in atorvastatin group) completed the study and were taken up for final analysis. Fasting blood samples were obtained at baseline and at 12 weeks to determine levels of blood glucose, lipid profile, insulin, C-peptide and glycosylated hemoglobin (A1C).
Atorvastatin nonsignificantly increased fasting serum insulin (+14.29%, p=0.18), accompanied by marginal nonsignificant increases in fasting plasma glucose and A1C. There was a decrease in HOMA2 percent beta-cell function (-2.9%, p=0.72) and increase in HOMA2 insulin resistance (+14%, p=0.16) in the atorvastatin group as compared with baseline, but the difference was not statistically significant.
Atorvastatin in the dose used failed to produce significant change in pancreatic beta-cell function and insulin resistance in type 2 diabetes patients as assessed by the HOMA2 index. The possible explanations include absence of lipotoxicity at prevailing levels of dyslipidemia at baseline or inadequacy of statin dose used in the study. (Clinical Trials Registry-India: CTRI/2008/091/000099).
他汀类药物常用于 2 型糖尿病患者的血脂异常管理。我们假设阿托伐他汀可以通过改变促凋亡和抗凋亡脂蛋白的水平来调节β细胞功能,并且还可能对胰岛素抵抗产生影响。本初步研究的目的是通过使用稳态模型评估-2(HOMA2)指数来评估阿托伐他汀 10mg 对血脂异常和 2 型糖尿病患者的胰岛β细胞功能和胰岛素抵抗的影响。
纳入 51 例正在服用口服降糖药物且未服用他汀类药物的 2 型糖尿病患者,基线时低密度脂蛋白胆固醇在 2.6mmol/L 至 4.1mmol/L 之间。43 例患者(安慰剂组 21 例,阿托伐他汀组 22 例)完成了研究并进行了最终分析。在基线和 12 周时采集空腹血样,以确定血糖、血脂谱、胰岛素、C 肽和糖化血红蛋白(A1C)水平。
阿托伐他汀治疗后空腹血清胰岛素水平升高(+14.29%,p=0.18),但空腹血糖和 A1C 升高不明显。阿托伐他汀组 HOMA2 胰岛β细胞功能下降(-2.9%,p=0.72),胰岛素抵抗增加(+14%,p=0.16),但与基线相比差异无统计学意义。
HOMA2 指数评估显示,阿托伐他汀在研究中使用的剂量未能使 2 型糖尿病患者的胰岛β细胞功能和胰岛素抵抗产生显著变化。可能的解释包括在基线时存在的血脂异常水平下不存在脂毒性,或者研究中使用的他汀类药物剂量不足。(印度临床试验注册中心:CTRI/2008/091/000099)。