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Multicenter, Open Label, Randomized Controlled Superiority Trial for Availability to Reduce Nocturnal Urination Frequency: Study Protocol for a TOP-STAR Study

Hanako Nakajima, Hiroshi Okada, Akinori Kogure, Takafumi Osaka, Takeshi Tsutsumi, Toru Tanaka, Goji Hasegawa, Shinichi Mogami, Kazuteru Mitsuhashi, Noriyuki Kitagawa, Yoshitaka Hashimoto, Miho Yano (+8 others)
2022 International Journal of Diabetology  

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Nocturia is a common disease in patients with type 2 diabetes mellitus that can reduce the quality of life. Sodium glucose co-transporter 2 (SGLT2) inhibitors increase the urine volume and are often discontinued when polyuria occurs, although tofogliflozin, which has a short half-life in the blood, may improve nocturia by managing hyperglycemia and hypertension, without aggravating nocturia. As excessive sodium intake worsens nocturia and increases urine volume, sodium restriction is also
more » ... ive in managing nocturia. This multicenter, open-label, randomized parallel-group trial will examine 80 patients with type 2 diabetes who experienced nocturia. After the baseline examination, the patients are randomly stratified into two groups and receive tofogliflozin treatment with or without sodium restriction for 12 weeks. The primary outcome is nocturia frequency at 12 weeks. The secondary outcomes are the frequency of daytime urine, changes in urine volume, and changes in home blood pressure.
doi:10.3390/diabetology3040048 fatcat:ljtxcvzn6nbyzmj7d53bnhy7me
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Hanako Nakajima, Hiroshi Okada, Akinori Kogure, Takafumi Osaka, Takeshi Tsutsumi, Toru Tanaka, Goji Hasegawa, Shinichi Mogami, Kazuteru Mitsuhashi, Noriyuki Kitagawa, Yoshitaka Hashimoto, Miho Yano, Muhei Tanaka, Akane Kitamura, Michiyo Ishii, Naoto Nakamura, Akio Kishi, Emi Ushigome, Masahide Hamaguchi, Michiaki Fukui. "Multicenter, Open Label, Randomized Controlled Superiority Trial for Availability to Reduce Nocturnal Urination Frequency: Study Protocol for a TOP-STAR Study." International Journal of Diabetology 3.4 (2022) 620-633