ω-3 脂肪酸联合格列美脲对 2 型糖尿病患者血糖控制、血脂谱、鸢尾素和 SIRT1 的影响：一项随机对照试验。

Effect of coadministration of omega-3 fatty acids with glimepiride on glycemic control, lipid profile, irisin, and sirtuin-1 in type 2 diabetes mellitus patients: a randomized controlled trial.

机构信息

Clinical Pharmacy & Pharmacy Practice, Faculty of Pharmacy, Damanhour University, Damanhour, 22514, Egypt.

Ministry of Health and Population, Damanhour City, Egypt.

出版信息

BMC Endocr Disord. 2023 Nov 25;23(1):259. doi: 10.1186/s12902-023-01511-2.

DOI:10.1186/s12902-023-01511-2

PMID:38001474

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10675938/

Abstract

BACKGROUND AND OBJECTIVE

Type 2 diabetes mellitus (T2DM) is caused by insulin resistance or tissue insensitivity to insulin, as well as relative insulin insufficiency. Diabetes that is uncontrolled for an extended period of time is linked to substantial comorbidities and organ damage. The purpose of the current study is to assess the effect of coadministration of omega-3 fatty acids with glimepiride on blood glucose, lipid profile, serum irisin, and sirtuin-1 levels in T2DM patients.

METHODS

This clinical trial involved 70 type 2 diabetic patients randomly assigned to glimepiride 3 mg with either omega-3 capsules contained fish oil 1000 mg, 13% of eicosapentaenoic acid (EPA) and 9% docosahexaenoic acid (DHA) (omega-3 group, n = 35) or placebo capsules contained corn oil and linoleic acid (control group, n = 35) daily for three months. Blood samples were obtained at the start of the study and 12 weeks later for biochemical examination of HbA1c%, FBG, fasting insulin, and lipid profile. In addition, the atherogenic index of plasma (AIP) was calculated. Human enzyme-linked immunosorbent assay (ELISA) kits were utilized for assessing serum irisin and sirtuin-1 levels before and after the intervention.

RESULTS

Compared to the control group, omega-3 fatty acids decreased serum fasting blood glucose (FBG, p < 0.001), glycated hemoglobin percent (HbA1C%, p < 0.001), total cholesterol (TC, p < 0.001), triglycerides (TGs, p = 0.006), low density lipoprotein (LDL, p = 0.089), and Homeostatic Model Assessment for Insulin Resistance (HOMA-IR, p = 0.021) after three months of intervention. However, a significant increase was reported in serum irisin and high density lipoprotein (HDL) between both groups after intervention (p = 0.026 and p = 0.007, respectively). The atherogenic index of plasma (AIP) increased in the control group but decreased in the omega-3 group, with significant differences between the two groups (p < 0.001).

CONCLUSION

The present study found that supplementing with omega-3 fatty acids might dramatically enhance blood irisin levels, as well as improve glycemic control and lipid profile in type 2 diabetes mellitus patients using glimepiride.

TRIAL REGISTRATION

This study is registered on ClinicalTrials.gov under identifier NCT03917940 . (The registration date: April 17, 2019).

摘要

背景与目的

2 型糖尿病（T2DM）是由胰岛素抵抗或组织对胰岛素不敏感以及相对胰岛素不足引起的。长期未得到控制的糖尿病与大量合并症和器官损伤有关。本研究旨在评估 omega-3 脂肪酸与格列美脲联合使用对 T2DM 患者血糖、血脂谱、血清鸢尾素和 Sirtuin-1 水平的影响。

方法

这项临床试验纳入了 70 例 2 型糖尿病患者，随机分为格列美脲 3mg 联合 omega-3 胶囊（含鱼油 1000mg，13%二十碳五烯酸（EPA）和 9%二十二碳六烯酸（DHA））（omega-3 组，n=35）或安慰剂胶囊（含玉米油和亚油酸）（对照组，n=35），每日一次，连续 3 个月。在研究开始时和 12 周后采集血液样本，用于生化检查糖化血红蛋白（HbA1c%）、空腹血糖（FBG）、空腹胰岛素和血脂谱。此外，还计算了血浆致动脉粥样硬化指数（AIP）。采用人酶联免疫吸附测定（ELISA）试剂盒检测血清鸢尾素和 Sirtuin-1 水平。

结果

与对照组相比，omega-3 脂肪酸降低了血清空腹血糖（FBG，p<0.001）、糖化血红蛋白（HbA1C%，p<0.001）、总胆固醇（TC，p<0.001）、甘油三酯（TGs，p=0.006）、低密度脂蛋白（LDL，p=0.089）和胰岛素抵抗稳态模型评估（HOMA-IR，p=0.021）。然而，两组干预后血清鸢尾素和高密度脂蛋白（HDL）均显著升高（p=0.026 和 p=0.007）。对照组血浆致动脉粥样硬化指数（AIP）升高，而 omega-3 组降低，两组间差异有统计学意义（p<0.001）。