Background

Body weight reduction is the first-line recommendation in NAFLD patients. Dapagliflozin has a strong potential to reduce body weight in addition to its glycemic control effect

Objective

To study the effect of dapagliflozin on various parameters in NAFLD type 2 diabetic patients.

Methods

In this randomized controlled trial, 150 type 2 diabetic patients with NAFLD diagnosed on the basis of radiological findings and deranged liver enzymes were randomly allocated into two groups. Both groups were taking tab glimepiride as a standard treatment of type 2 diabetes. Group A was given tab dapagliflozin 5–10 mg while group B was given tab placebo in addition to lifestyle modifications for a period of 12 weeks. Body weight, BMI, HbA1c, and serum aminotransferases were analyzed pre- and post-treatment using SPSS 20.

Results

After 12 weeks of treatment, glycemic control was improved in both study groups, i.e., dapagliflozin (FBS from 95 ± 14 to 80 ± 11 mg/dl with p = 0.003, HbAIc from 7.5 ± 4.5 to 6.4 ± 5.4% with p = 0.002) and placebo (FBS from 100 ± 9.5 to 90.5 ± 13 mg/dl with p = 0.004, HbA1c from 8.2 ± 3.5 to7.6 ± 4.2% with p = 0.006). However, the dapagliflozin group showed a significant reduction in FBS and HbA1c as compared to placebo with p value 0.006 and 0.04 respectively. Body weight was significantly reduced in the dapagliflozin group (from 90 ± 13.5 to 84 ± 11.6) as compared to the placebo group (from 85 ± 17.8 to 85.5 ± 13.7) with p = 0.002. BMI also reduced in the dapagliflozin group (from 29.5 ± 2.5 to 26.5 ± 3.5) versus the placebo group (from 31.5 ± 3.0 to 29.5 ± 4.2) with p = 0.002. There was also significant reduction in ALT in the dapagliflozin group from 69 ± 15.5 to 52 ± 12.8 versus placebo from 68 ± 20.5 with p = 0.04 and AST from 74 ± 13 to 47 ± 13.5 versus placebo from 71 ± 12.5 to 65 ± 10.5 with p = 0.02

Conclusion

Dapagliflozin has a strong potential to reverse NAFLD-associated changes in type 2 diabetic patients.

中文翻译：

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达格列净对非酒精性脂肪性肝病 (NAFLD) 患者各种参数的治疗结果

背景

减轻体重是 NAFLD 患者的一线推荐。达格列净除了具有血糖控制作用外，还具有减轻体重的巨大潜力

客观的

研究达格列净对 NAFLD 2 型糖尿病患者各项指标的影响。

方法

在这项随机对照试验中，150 名根据放射学检查结果和肝酶紊乱诊断为 NAFLD 的 2 型糖尿病患者被随机分为两组。两组都将格列美脲片作为 2 型糖尿病的标准治疗方法。A 组服用达格列净 5-10 mg，而 B 组除生活方式改变外还服用安慰剂，持续 12 周。使用 SPSS 20 分析治疗前后的体重、BMI、HbA1c 和血清转氨酶。

结果

治疗 12 周后，两个研究组的血糖控制均得到改善，即达格列净（FBS 从 95 ± 14 到 80 ± 11 mg/dl，p = 0.003，HbAlc 从 7.5 ± 4.5 到 6.4 ± 5.4%，p = 0.002 ) 和安慰剂（FBS 从 100 ± 9.5 到 90.5 ± 13 mg/dl，p = 0.004，HbA1c 从 8.2 ± 3.5 到 7.6 ± 4.2%，p = 0.006）。然而，与安慰剂相比，达格列净组的 FBS 和 HbA1c 显着降低，p 值分别为 0.006 和 0.04。与安慰剂组（从 85±17.8 到 85.5±13.7）相比，达格列净组的体重显着降低（从 90±13.5 到 84±11.6），p = 0.002。与安慰剂组（从 31.5±3.0 到 29.5±4.2）相比，达格列净组（从 29.5±2.5 到 26.5±3.5）的 BMI 也降低，p = 0.002。

结论

Dapagliflozin 具有逆转 2 型糖尿病患者 NAFLD 相关变化的强大潜力。