ArticleDiabetes therapy : research, treatment and education of diabetes and related disorders2026
Study Protocol for the TIGHTEN Study Comparing the Effects of Tofogliflozin and Glimepiride on Skeletal Muscle Mass in Patients with Type 2 Diabetes without Obesity: A Prospective, Multicenter, Open-Label, Randomized, Parallel Group Trial in Japan.
Article in Diabetes therapy : research, treatment and education of diabetes and related disorders, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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Abstract
introductionAlthough sodium-glucose cotransporter 2 (SGLT2) inhibitors are associated with a lower risk of hypoglycemia, they may result in weight reduction, and provide additional benefits for cardiovascular disease, chronic kidney disease, and heart failure. However, their use in Japanese individuals with type 2 diabetes (T2D)-many of whom are older and without obesity-raises concerns regarding sarcopenia. This study aims to investigate the impact of the SGLT2 inhibitor tofogliflozin, compared with sulfonylurea glimepiride, on skeletal muscle mass in patients with T2D without obesity.
methodsThis study is a prospective, multicenter, open-label, randomized, parallel group, comparative trial. Adult Japanese patients with T2D with a body mass index of < 25 kg/m PLANNED OUTCOMES: Participant recruitment commenced in April 2024 and concluded in June 2025. The complete findings of this study are anticipated to be published in 2027. We expect that the results will elucidate the impact of SGLT2 inhibitors on skeletal muscle mass in individuals with T2D without obesity, thereby addressing concerns related to sarcopenia.
trial registrationJapan Registry of Clinical Trials (jRCT) (No. jRCTs041240011); registered 10 April 2024, https://jrct.mhlw.go.jp/en-latest-detail/jRCTs041240011 .
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