在持续服用二甲双胍的基础上加用西他列汀对 2 型糖尿病和非酒精性脂肪肝患者的代谢概况、甘油三酯-葡萄糖指数、维生素 D3 和肝脏检测的疗效：双盲随机临床试验

IF 1.6 Q3 MEDICINE, RESEARCH & EXPERIMENTAL

Current Therapeutic Research-clinical and Experimental Pub Date : 2024-01-01 DOI:10.1016/j.curtheres.2024.100764

Habib Yaribeygi PhD , Majid Ramezani MD , Niki Katsiki PhD, MD , Majid Mirmohammadkhani PhD , Narges Sadat Tabaei Msc

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引用次数: 0

摘要

背景二肽基肽酶-4抑制剂对2型糖尿病（T2DM）患者具有强效的抗糖尿病作用，但其在非酒精性脂肪肝（NAFLD）患者中的作用尚不为人所知。本临床试验旨在评估西格列汀对二甲双胍治疗的 T2DM 和非酒精性脂肪肝患者的代谢状况和肝脏检测结果的影响。方法这是一项前瞻性、为期 12 周、单中心、比较性随机临床试验，共招募了 66 名 T2DM 和非酒精性脂肪肝（经超声诊断）的成年患者。患者被随机分配到二甲双胍（2000 毫克/天，n = 33）或西他列汀+二甲双胍（分别为 100 毫克/天和 2000 毫克/天，n = 33），口服给药。在基线和 12 周后测量了某些代谢参数，即空腹血糖 (FBS)、糖化血红蛋白、甘油三酯 (TGs)、总胆固醇 (TC)、低密度脂蛋白胆固醇、维生素 D3 (vitD3)、碱性磷酸酶、丙氨酸氨基转移酶 (SGPT) 和天冬氨酸氨基转移酶。结果西他列汀+二甲双胍组的所有生化变量下降幅度均大于二甲双胍组，其中FBS（P = 0.030）、TC（P = 0.017）、TG（P = 0.008）、SGPT（P = 0.018）和维生素D3（P = 0.001）的差异具有统计学意义。结论与二甲双胍单药治疗组相比，西格列汀+二甲双胍治疗可显著改善 FBS、TC、TG、SGPT、vitD3 和 TG-G。西格列汀+二甲双胍组的其他生物标志物也比二甲双胍组下降得更多，但这些差异未达到统计学意义。本研究结果表明，在二甲双胍治疗的 T2DM 和非酒精性脂肪肝患者中加用西他列汀后可获得一定的代谢益处，但对这些结果的解释仍需谨慎。还需要进一步的研究来阐明这些效果，并为得出安全的结论提供有力的证据。

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Efficacy of Adding Sitagliptin to Ongoing Metformin on Metabolic Profile, Triglyceride-Glucose Index, Vitamin D3, and Liver Tests in Patients Type 2 Diabetes Mellitus and Nonalcoholic Fatty Liver Disease: A Double-Blind Randomized Clinical Trial

Background

Dipeptidyl peptidase-4 inhibitors provide potent antidiabetic effects in patients with type 2 diabetes mellitus (T2DM), but their role in the presence of nonalcoholic fatty liver disease (NAFLD) is not well-known.

Objective

The aim of this clinical trial was to evaluate the effects of sitagliptin on the metabolic profile and liver test results in metformin-treated patients with T2DM and NAFLD.

Methods

This was a prospective, 12-week, single-center, comparative randomized clinical trial enrolling 66 adult patients with T2DM and NAFLD (diagnosed by ultrasound). Patients were randomly assigned to either metformin (2000 mg/d, n = 33) or sitagliptin + metformin (100 and 2000 mg/d, respectively, n = 33), administered orally. Certain metabolic parameters, that is, fasting blood sugar (FBS), glycosylated hemoglobin, triglycerides (TGs), total cholesterol (TC), low-density lipoprotein cholesterol, vitamin D3 (vitD3), alkaline phosphatase, alanine aminotransferase (SGPT), and aspartate aminotransferase, were measured at baseline and after 12 weeks. Triglyceride-glucose (TG-G) index was also calculated.

Results

All biochemical variables decreased by a greater extent in the sitagliptin + metformin group than in the metformin group, with differences in FBS (P = 0.030), TC (P = 0.017), TG (P = 0.008), SGPT (P = 0.018), and vitD3 (P = 0.001) reaching statistical significance. Furthermore, the mean reduction of the TG-G index was significantly greater in the sitagliptin + metformin group than in the metformin group (0.67 vs 0.21, respectively; P = 0.017).

Conclusions

Sitagliptin + metformin therapy led to significantly greater improvements in FBS, TC, TG, SGPT, vitD3, and TG-G compared with the metformin monotherapy group. Other biomarkers also decreased more in the sitagliptin + metformin group than in the metformin group, but these differences did not reach statistical significance. The present findings should be interpreted with caution, although they suggest certain metabolic benefits after sitagliptin addition in metformin-treated patients with T2DM and NAFLD. Further studies are required to elucidate these effects and provide strong evidence for safe conclusions.

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来源期刊

Current Therapeutic Research-clinical and Experimental 医学-药学

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

3 months

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