Twelve week liraglutide or sitagliptin does not affect hepatic fat in type 2 diabetes: a randomised placebo-controlled trial.

Twelve week liraglutide or sitagliptin does not affect hepatic fat in type 2 diabetes: a randomised placebo-controlled trial.
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DOI:
10.1007/s00125-016-4100-7
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发表时间:
2016-12
期刊:
影响因子:
8.2
通讯作者:
Cahen DL
Cahen DL
中科院分区:
医学1区
文献类型:
--
作者:
Smits MM;Tonneijck L;Muskiet MH;Kramer MH;Pouwels PJ;Pieters-van den Bos IC;Hoekstra T;Diamant M;van Raalte DH;Cahen DL

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已建议基于胰高血糖素样肽(GLP)-1的治疗可改善肝脂肪变性。我们评估了GLP-1受体激动剂利拉鲁肽和二肽基肽酶(DPP)-4抑制剂西格列汀对2型糖尿病患者肝脂肪变性和纤维化的影响。这项为期12周的平行、随机、安慰剂对照试验于2013年7月至2015年8月在VU大学医学中心进行,52例接受二甲双胍和/或磺脲类药物治疗的超重2型糖尿病患者([平均值± SD]年龄62.7 ± 6.9岁,HbA 1c 7.3 ± 0.7%或56 ± 1 mmol/mol)分配至利拉鲁肽1.8 mg每日一次组(n = 17),西格列汀100 mg(n = 18)或匹配安慰剂(n = 17)通过计算机生成的数字。参与者和研究人员都对分组不知情。采用质子磁共振波谱(1H-MRS)测量肝脏脂肪含量。使用三个经验证的公式估计肝纤维化。西格列汀组有1例患者因头晕退出,但未发生严重不良事件。第12周时,未发现肝脂肪变性的组间差异,利拉鲁肽使脂肪变性减少10%(20.9 ± 3.4%至18.8 ± 3.3%),西格列汀使脂肪变性减少12.1%(23.9 ± 3.0%至21.0 ± 2.7%),安慰剂使脂肪变性减少9.5%(18.7 ± 2.7%至16.9 ± 2.7%)。与安慰剂相比,两种药物均不影响肝纤维化评分。利拉鲁肽或西格列汀治疗10周不能减少2型糖尿病患者的肝脂肪变性或纤维化。ClinicalTrials.gov NCT 01744236由欧洲共同体第七框架计划(FP 7/2007-2013)根据第282521号赠款协议资助-SAFEGUARD项目。本文的在线版本(doi:10.1007/s 00125 -016-4100-7)包含同行评审但未经编辑的补充材料,可供授权用户使用。
Glucagon-like peptide (GLP)-1-based therapies have been suggested to improve hepatic steatosis. We assessed the effects of the GLP-1 receptor agonist liraglutide and the dipeptidyl peptidase (DPP)-4 inhibitor sitagliptin on hepatic steatosis and fibrosis in patients with type 2 diabetes. In this 12 week, parallel, randomised, placebo-controlled trial, performed at the VU University Medical Center between July 2013 and August 2015, 52 overweight patients with type 2 diabetes treated with metformin and/or sulphonylurea agent ([mean ± SD] age 62.7 ± 6.9 years, HbA1c 7.3 ± 0.7% or 56 ± 1 mmol/mol) were allocated to once daily liraglutide 1.8 mg (n = 17), sitagliptin 100 mg (n = 18) or matching placebos (n = 17) by computer generated numbers. Both participants and researchers were blinded to group assignment. Hepatic fat content was measured using proton magnetic resonance spectroscopy (1H-MRS). Hepatic fibrosis was estimated using three validated formulae. One patient dropped out in the sitagliptin group owing to dizziness, but no serious adverse events occurred. At week 12, no between-group differences in hepatic steatosis were found. Liraglutide reduced steatosis by 10% (20.9 ± 3.4% to 18.8 ± 3.3%), sitagliptin reduced steatosis by 12.1% (23.9 ± 3.0% to 21.0 ± 2.7%) and placebo lessened it by 9.5% (18.7 ± 2.7% to 16.9 ± 2.7%). Neither drug affected hepatic fibrosis scores compared with placebo. Twelve-week liraglutide or sitagliptin treatment does not reduce hepatic steatosis or fibrosis in type 2 diabetes. ClinicalTrials.gov NCT01744236 Funded by the European Community’s Seventh Framework Programme (FP7/2007-2013) under grant agreement no. 282521 – the SAFEGUARD project. The online version of this article (doi:10.1007/s00125-016-4100-7) contains peer-reviewed but unedited supplementary material, which is available to authorised users.
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