Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study)
Background To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of a...
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2025-03-01
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| author | Masahiro Yamazaki Michiaki Fukui Masahide Hamaguchi Yoshitaka Hashimoto Toru Tanaka Noriyuki Kitagawa Shinichi Mogami Akinori Kogure Michiyo Ishii Naoto Nakamura Hiroshi Okada Takuya Fukuda Takeshi Tsutsumi Takafumi Osaka Junya Hironaka Genki Kobayashi Muhei Tanaka Kazuteru Mitsuhashi Takashi Yoshimura Miho Yano Akane Kitamura Akio Kishi Ryo Bamba Eiko Sato |
| author_facet | Masahiro Yamazaki Michiaki Fukui Masahide Hamaguchi Yoshitaka Hashimoto Toru Tanaka Noriyuki Kitagawa Shinichi Mogami Akinori Kogure Michiyo Ishii Naoto Nakamura Hiroshi Okada Takuya Fukuda Takeshi Tsutsumi Takafumi Osaka Junya Hironaka Genki Kobayashi Muhei Tanaka Kazuteru Mitsuhashi Takashi Yoshimura Miho Yano Akane Kitamura Akio Kishi Ryo Bamba Eiko Sato |
| author_sort | Masahiro Yamazaki |
| collection | DOAJ |
| description | Background To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of administering sodium zirconium cyclosilicate (SZC) to patients with type 2 diabetes mellitus (T2DM) complicated by hyperkalaemia.Methods and analysis A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g once daily) will subsequently commence in group A, while dietary therapy will be initiated in group B by implementing a potassium-restricted diet. The primary endpoint of the study is the proportion of normokalaemic (3.5 mEq/L≤serum potassium (sK)<5.0 mEq/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq/L≤sK<5.0 mEq/L) at visit 4 and (b) serum potassium levels at visit 7.Ethics and dissemination Written informed consent will be obtained from all participants prior to commencing the study. This study has been approved by the Kyoto Prefectural University of Medicine Clinical Research Review Board. All data obtained from this study will be published in a peer-reviewed journal.Trial registration number jRCTs051230067. |
| format | Article |
| id | doaj-art-2dde561bfc234cc29cb580af84a55268 |
| institution | DOAJ |
| issn | 2044-6055 |
| language | English |
| publishDate | 2025-03-01 |
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| spelling | doaj-art-2dde561bfc234cc29cb580af84a552682025-08-20T02:46:28ZengBMJ Publishing GroupBMJ Open2044-60552025-03-0115310.1136/bmjopen-2024-089564Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study)Masahiro Yamazaki0Michiaki Fukui1Masahide Hamaguchi2Yoshitaka Hashimoto3Toru Tanaka4Noriyuki Kitagawa5Shinichi Mogami6Akinori Kogure7Michiyo Ishii8Naoto Nakamura9Hiroshi Okada10Takuya Fukuda11Takeshi Tsutsumi12Takafumi Osaka13Junya Hironaka14Genki Kobayashi15Muhei Tanaka16Kazuteru Mitsuhashi17Takashi Yoshimura18Miho Yano19Akane Kitamura20Akio Kishi21Ryo Bamba22Eiko Sato2314 Kyoto Second Red Cross Hospital, Kyoto, Japan1 Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan9 Department of Diabetology, Kameoka Municipal Hospital, Kameoka, Japan3 Matsushita Memorial Hospital, Moriguchi, Japan19 Japanese Red Cross Kyoto Daiichi Hospital, Kyoto, Japan9 Department of Diabetology, Kameoka Municipal Hospital, Kameoka, Japan16 Department of Endocrinology, Metabolism, and Diabetes, Saiseikai Suita Hospital, Osaka, Japan6 Department of Diabetes and Metabolic Medicine, Kyoto City Hospital, Kyoto, Japan15 Department of Internal Medicine, Otsu City Hospital, Otsu, Japan17 Kyoto Saiseikai Hospital, Nagaokakyo, Japan1 Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan18 Amanogawa Hospital, Kishiwada, Japan13 Kyoto Yamashiro General Medical Center, Kizugawa, Japan2 Ayabe City Hospital, Ayabe, Japan1 Department of Endocrinology and Metabolism, Kyoto Prefectural University of Medicine School of Medicine Graduate School of Medical Science, Kyoto, Japan4 Aiseikai Ymashina Hospital, Kyoto, Japan5 Shiritsu Suita Shimin Byoin, Suita, Japan7 Department of Diabetes Internal Medicine, Fukuchiyama City Hospital, Fukuchiyama, Japan8 Akashi City Hospital, Akashi, Japan10 Department of Diabetology, Nishijin Hospital, Kyoto, Japan11 Department of Diabetology, Nagitsuji Hospital, Kyoto, Japan12 Department of Diabetes, Kyoto Okamoto Memorial Hospital, Kuze-gun, Japan20 Kyoto Chubu Medical Center, Nantan, Japan21 Ashikaga University, Ashikaga, JapanBackground To effectively manage the progression of diabetic kidney disease, it is essential to address the associated hyperkalaemia while concurrently using renin-angiotensin-aldosterone system inhibitors and mineralocorticoid receptor antagonists. In this study, we aim to evaluate the effects of administering sodium zirconium cyclosilicate (SZC) to patients with type 2 diabetes mellitus (T2DM) complicated by hyperkalaemia.Methods and analysis A total of 80 patients with type 2 diabetes and hyperkalaemia will be included in the study and randomly stratified into two groups.After consent, both groups will enter an initiation phase, receiving 10 g of SZC, three times per day for 2 days. SZC administration (5 g once daily) will subsequently commence in group A, while dietary therapy will be initiated in group B by implementing a potassium-restricted diet. The primary endpoint of the study is the proportion of normokalaemic (3.5 mEq/L≤serum potassium (sK)<5.0 mEq/L) participants at visit 7. The secondary endpoints are: (a) the proportion of normokalaemic participants (3.5 mEq/L≤sK<5.0 mEq/L) at visit 4 and (b) serum potassium levels at visit 7.Ethics and dissemination Written informed consent will be obtained from all participants prior to commencing the study. This study has been approved by the Kyoto Prefectural University of Medicine Clinical Research Review Board. All data obtained from this study will be published in a peer-reviewed journal.Trial registration number jRCTs051230067.https://bmjopen.bmj.com/content/15/3/e089564.full |
| spellingShingle | Masahiro Yamazaki Michiaki Fukui Masahide Hamaguchi Yoshitaka Hashimoto Toru Tanaka Noriyuki Kitagawa Shinichi Mogami Akinori Kogure Michiyo Ishii Naoto Nakamura Hiroshi Okada Takuya Fukuda Takeshi Tsutsumi Takafumi Osaka Junya Hironaka Genki Kobayashi Muhei Tanaka Kazuteru Mitsuhashi Takashi Yoshimura Miho Yano Akane Kitamura Akio Kishi Ryo Bamba Eiko Sato Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study) BMJ Open |
| title | Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study) |
| title_full | Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study) |
| title_fullStr | Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study) |
| title_full_unstemmed | Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study) |
| title_short | Non-inferiority of sodium zirconium cyclosilicate versus potassium-restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus: protocol for a multicentre, open-label, randomised controlled, two-arm clinical trial (SILVERSTAR study) |
| title_sort | non inferiority of sodium zirconium cyclosilicate versus potassium restricted diet in achieving normokalaemia in patients with type 2 diabetes mellitus protocol for a multicentre open label randomised controlled two arm clinical trial silverstar study |
| url | https://bmjopen.bmj.com/content/15/3/e089564.full |
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