依帕列净与二甲双胍对老年2型糖尿病患者内脏脂肪减少作用的比较：一项随机对照研究的亚组分析
Comparison of Visceral Fat Reduction by Ipragliflozin and Metformin in Elderly Type 2 Diabetes Patients: Sub-Analysis of a Randomized-Controlled Study.
作者信息
Koshizaka Masaya, Ishikawa Ko, Ishibashi Ryoichi, Takahashi Sho, Sakamoto Kenichi, Yokoh Hidetaka, Baba Yusuke, Ide Shintaro, Ide Kana, Ishikawa Takahiro, Onishi Shunichiro, Kobayashi Kazuki, Takemoto Minoru, Horikoshi Takuro, Shimofusa Ryota, Maezawa Yoshiro, Yokote Koutaro
机构信息
Department of Diabetes, Metabolism and Endocrinology, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8677, Japan.
Department of Endocrinology, Hematology and Gerontology, Chiba University Graduate School of Medicine, 1-8-1 Inohana, Chuo-ku, Chiba City, Chiba, 260-8670, Japan.
出版信息
Diabetes Ther. 2021 Jan;12(1):183-196. doi: 10.1007/s13300-020-00949-0. Epub 2020 Oct 24.
INTRODUCTION
To compare the effects of ipragliflozin, a sodium-glucose transporter 2 inhibitor, with those of metformin on visceral fat (as well as muscles and bones) in Japanese elderly patients with type 2 diabetes (T2D), we conducted a sub-analysis of a prospective, multicenter, blinded-endpoint randomized-controlled study.
METHODS
In total, 103 patients with T2D (body mass index ≥ 22 kg/m; glycated hemoglobin, 7-10%) and being treated with sitagliptin (a dipeptidyl peptidase-4 inhibitor) were included and randomized to receive ipragliflozin or metformin. The primary outcome was the change in visceral fat area measured using computed tomography 24 weeks following treatment. The secondary outcomes included changes in subcutaneous and total fat area, muscle volume, bone density measured using computed tomography, handgrip strength, bone markers, plasma glucose, insulin, homeostasis model assessment (HOMA)2-beta, HOMA2-R, glycated hemoglobin, lipid panel, uric acid, blood pressure, adiponectin, and high-sensitivity C-reactive protein. All patients aged 65-74 years were selected for sub-analysis.
RESULTS
The sub-analysis included 15 and 14 patients in the ipragliflozin and metformin groups, respectively. The patients' backgrounds were well balanced. Visceral fat area reduction was greater in the ipragliflozin group than in the metformin group (- 10.58% vs. - 6.93%; P = 0.034). There were significant differences in the changes in bone absorption markers, uric acid, and total cholesterol levels between the groups.
CONCLUSION
Ipragliflozin significantly reduced the visceral fat area compared with metformin when added to sitagliptin in elderly patients with T2D. Long-term and large-scale studies are required to elucidate whether ipragliflozin is suitable for elderly patients.
TRIAL REGISTRATION
The study was registered at https://www.umin.ac.jp/ctr/ (UMIN-ID: UMIN 000015170).
引言
为比较钠-葡萄糖协同转运蛋白2抑制剂依帕列净与二甲双胍对日本老年2型糖尿病（T2D）患者内脏脂肪（以及肌肉和骨骼）的影响，我们对一项前瞻性、多中心、双盲终点随机对照研究进行了亚组分析。
方法
总共纳入103例接受西他列汀（一种二肽基肽酶-4抑制剂）治疗的T2D患者（体重指数≥22kg/m²；糖化血红蛋白7%-10%），并随机分为依帕列净组或二甲双胍组。主要结局是治疗24周后使用计算机断层扫描测量的内脏脂肪面积变化。次要结局包括皮下和总脂肪面积变化、肌肉体积、使用计算机断层扫描测量的骨密度、握力、骨标志物、血糖、胰岛素、稳态模型评估（HOMA）2-β、HOMA2-R、糖化血红蛋白、血脂谱、尿酸、血压、脂联素和高敏C反应蛋白。所有年龄在65-74岁的患者被选入亚组分析。
结果
亚组分析中，依帕列净组和二甲双胍组分别有15例和14例患者。两组患者的背景均衡。依帕列净组的内脏脂肪面积减少幅度大于二甲双胍组（-10.58%对-6.93%；P=0.034）。两组之间在骨吸收标志物、尿酸和总胆固醇水平变化方面存在显著差异。
结论
在老年T2D患者中，依帕列净与西他列汀联用时，与二甲双胍相比能显著降低内脏脂肪面积。需要进行长期和大规模研究以阐明依帕列净是否适合老年患者。
试验注册
该研究在https://www.umin.ac.jp/ctr/（UMIN编号：UMIN 000015170）注册。
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