Watanabe Yasuhiro, Kuribayashi Nobuichi, Uchida Daigaku, Suzuki Daisuke, Kato Mitsutoshi, Nagayama Daiji, Ohashi Hiroshi, Ohira Masahiro, Saiki Atsuhito, Tatsuno Ichiro
Center of Diabetes, Endocrinology and Metabolism, Toho University Sakura Medical Center, Chiba, Japan.
Misaki Naika Clinic, Chiba, Japan.
Diabetes Ther. 2019 Feb;10(1):311-321. doi: 10.1007/s13300-018-0555-5. Epub 2018 Dec 21.
Sodium-dependent glucose transporter-2 (SGLT2) inhibitors such as dapagliflozin induce weight loss, but the mechanism is thought to involve loss of both body fat and skeletal muscle mass. The decrease in skeletal muscle mass may lead to worsening of insulin resistance in type 2 diabetes patients. On the other hand, formula diet (FD) is a low-calorie food containing low carbohydrates, low fat, and sufficient protein, vitamins, and minerals to support a healthy and balanced diet, and is used for the treatment of obesity or diabetes. Therefore, we examine whether the protein supplementation is superior to the fat supplementation in metabolic improvement of the poorly controlled type 2 diabetes patients treated with SGLT2 inhibitor. We compare the therapeutic effects using two types of FD; a high protein FD and a high fat FD. Patients are prescribed dapagliflozin and replacement of one of three meals with FD. We compare high protein FD and high fat FD with respect to improvement of glycemic control while maintaining skeletal muscle mass.
We conduct a prospective, multicenter, double-blinded, randomized, controlled, investigator-initiated clinical trial. Patients who satisfy the eligibility criteria will be randomized to two groups (1:1) and prescribed 5 mg of dapagliflozin once daily together with a high protein FD or high fat FD (same number of calories) to replace one of three meals a day (one meal with FD only and two normal meals). The observation period for both groups is 24 weeks. The primary endpoint is the change in HbA1c.
This study is ongoing and scheduled to complete in June 2019. The findings of this study will be disseminated through peer-reviewed publications and conference presentations.
University Hospital Medical Information Network (UMIN) 000024580.
This study was carried out under contract with the specified nonprofit corporation Hokkaido Institute of Health Sciences, based on a grant from AstraZeneca Co., Ltd. and Ono Pharmaceutical Co., Ltd. for an investigator-initiated clinical trial. The authors funded the journals article processing charges.
达格列净等钠依赖性葡萄糖转运蛋白2（SGLT2）抑制剂可导致体重减轻，但其机制被认为与体脂和骨骼肌质量的减少均有关。骨骼肌质量的下降可能会导致2型糖尿病患者的胰岛素抵抗恶化。另一方面，配方饮食（FD）是一种低热量食物，含有低碳水化合物、低脂肪以及足够的蛋白质、维生素和矿物质，以支持健康均衡的饮食，可用于治疗肥胖症或糖尿病。因此，我们研究了在使用SGLT2抑制剂治疗的血糖控制不佳的2型糖尿病患者中，补充蛋白质是否比补充脂肪在代谢改善方面更具优势。我们比较两种类型的配方饮食（FD）的治疗效果；一种高蛋白FD和一种高脂肪FD。患者服用达格列净，并使用FD替代三餐中的一餐。我们比较高蛋白FD和高脂肪FD在维持骨骼肌质量的同时改善血糖控制的情况。
我们进行一项前瞻性、多中心、双盲、随机、对照、研究者发起的临床试验。符合入选标准的患者将被随机分为两组（1:1），并每日一次服用5mg达格列净，同时搭配高蛋白FD或高脂肪FD（热量相同）以替代一天三餐中的一餐（仅一餐用FD，另外两餐为正常饮食）。两组的观察期均为24周。主要终点是糖化血红蛋白（HbA1c）的变化。
本研究正在进行中，计划于2019年6月完成。本研究的结果将通过同行评审的出版物和会议报告进行传播。
大学医院医学信息网络（UMIN）000024580。
本研究是根据与特定非营利性公司北海道健康科学研究所签订的合同进行的，该合同基于阿斯利康有限公司和小野制药有限公司为一项研究者发起的临床试验提供的资助。作者支付了期刊文章处理费用。
