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,
Muhei Tanaka,
Akane Kitamura,
Michiyo Ishii,
Naoto Nakamura,
Akio Kishi,
Emi Ushigome,
Masahide Hamaguchi,
Michiaki Fukui
Affiliations
Hanako Nakajima
Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Hiroshi Okada
Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Akinori Kogure
Department of Diabetes and Metabolic Medicine, Kyoto City Hospital, Kyoto 604-8845, Japan
Takafumi Osaka
Department of Endocrinology and Diabetology, Ayabe City Hospital, Ayabe 623-0011, Japan
Takeshi Tsutsumi
Department of Endocrinology and Metabolism, Kyoto Yamashiro General Medical Center, Kizugawa 619-0214, Japan
Toru Tanaka
Department of Diabetes and Endocrinology, Japanese Red Cross Kyoto Daiichi Hospital, Kyoto 605-0981, Japan
Goji Hasegawa
Division of Metabolism, Nephrology and Rheumatology, Japanese Red Cross Kyoto Daini Hospital, Kyoto 602-8026, Japan
Shinichi Mogami
Department of Diabetes and Metabolism, Osaka General Hospital of West Japan Railway Company, Osaka 545-0053, Japan
Kazuteru Mitsuhashi
Department of Diabetes and Internal Medicine, Fukuchiyama City Hospital, Fukuchiyama 620-8505, Japan
Noriyuki Kitagawa
Department of Diabetology, Kameoka Municipal Hospital, Kameoka 621-0826, Japan
Yoshitaka Hashimoto
Department of Diabetes and Endocrinology, Matsushita Memorial Hospital, Moriguchi 570-8540, Japan
Miho Yano
Department of Diabetology, Nishijin Hospital, Kyoto 602-8319, Japan
Muhei Tanaka
Department of Endocrinology, Metabolism, and Diabetes, Saiseikai Suita Hospital, Osaka 564-0013, Japan
Akane Kitamura
Department of Diabetology, Nagitsuji Hospital, Kyoto 607-8163, Japan
Michiyo Ishii
Department of Internal Medicine, Otsu City Hospital, Otsu 520-0804, Japan
Naoto Nakamura
Division of Diabetes, Saiseikai Kyoto Hospital, Kyoto 617-8617, Japan
Akio Kishi
Department of Diabetes, Kyoto Okamoto Memorial Hospital, Kyoto 613-0034, Japan
Emi Ushigome
Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Masahide Hamaguchi
Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
Michiaki Fukui
Department of Endocrinology and Metabolism, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, Kyoto 602-8566, Japan
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 effective 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.
