Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial
Abstract Background Low-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused on comparing calorie-restricted LCD to iso-caloric low-fat diets. In t...
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BMC
2023-06-01
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| Series: | Trials |
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| Online Access: | https://doi.org/10.1186/s13063-023-07427-5 |
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| author | Xinyi Xia Miao Xu Yunjie Gu Yangxue Li Li Li Jun Yin |
| author_facet | Xinyi Xia Miao Xu Yunjie Gu Yangxue Li Li Li Jun Yin |
| author_sort | Xinyi Xia |
| collection | DOAJ |
| description | Abstract Background Low-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused on comparing calorie-restricted LCD to iso-caloric low-fat diets. In this study, we aim to compare the effects of LCD and canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with T2DM. Methods This is a multicenter, randomized controlled trial. We will recruit 120 patients with poor-controlled T2DM. Participants will be randomly divided into canagliflozin and LCD groups in a 1:1 ratio. The primary outcome is the change in hemoglobin A1C levels after the 3-month intervention. The secondary outcomes are the time in range and cost of antihyperglycemic agents. Exploratory outcomes include physical examination, body composition, glucose variability, appetite, glycolipid metabolism, liver lipid content, and urine glucose threshold. Discussion No previous study has compared an LCD with antihyperglycemic agents. In LoCaT, participants’ metabolism will be assessed from multiple perspectives. It is believed that the finding obtained from this trial will optimize the treatments for patients with T2DM. Trial registration Chinese Clinical Trial Registry ChiCTR1900027592. Registered on November 20, 2019. |
| first_indexed | 2024-03-13T03:19:34Z |
| format | Article |
| id | doaj.art-d67976757e184fadb57444e93f368c7f |
| institution | Directory Open Access Journal |
| issn | 1745-6215 |
| language | English |
| last_indexed | 2024-03-13T03:19:34Z |
| publishDate | 2023-06-01 |
| publisher | BMC |
| record_format | Article |
| series | Trials |
| spelling | doaj.art-d67976757e184fadb57444e93f368c7f2023-06-25T11:26:52ZengBMCTrials1745-62152023-06-012411810.1186/s13063-023-07427-5Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trialXinyi Xia0Miao Xu1Yunjie Gu2Yangxue Li3Li Li4Jun Yin5Department of Endocrinology and Metabolism, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes MellitusDepartment of Endocrinology and Metabolism, Ningbo First HospitalDepartment of Endocrinology and Metabolism, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes MellitusDepartment of Endocrinology and Metabolism, Shanghai Eighth People’s HospitalDepartment of Endocrinology and Metabolism, Ningbo First HospitalDepartment of Endocrinology and Metabolism, Shanghai Sixth People’s Hospital Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai Clinical Center for Diabetes, Shanghai Diabetes Institute, Shanghai Key Laboratory of Diabetes MellitusAbstract Background Low-carbohydrate diet (LCD) is an emerging therapy for type 2 diabetes mellitus (T2DM). Although its effect on glucose control has been confirmed in previous clinical trials, most of those studies have focused on comparing calorie-restricted LCD to iso-caloric low-fat diets. In this study, we aim to compare the effects of LCD and canagliflozin, a sodium-glucose cotransporter 2 inhibitor, in patients with T2DM. Methods This is a multicenter, randomized controlled trial. We will recruit 120 patients with poor-controlled T2DM. Participants will be randomly divided into canagliflozin and LCD groups in a 1:1 ratio. The primary outcome is the change in hemoglobin A1C levels after the 3-month intervention. The secondary outcomes are the time in range and cost of antihyperglycemic agents. Exploratory outcomes include physical examination, body composition, glucose variability, appetite, glycolipid metabolism, liver lipid content, and urine glucose threshold. Discussion No previous study has compared an LCD with antihyperglycemic agents. In LoCaT, participants’ metabolism will be assessed from multiple perspectives. It is believed that the finding obtained from this trial will optimize the treatments for patients with T2DM. Trial registration Chinese Clinical Trial Registry ChiCTR1900027592. Registered on November 20, 2019.https://doi.org/10.1186/s13063-023-07427-5Type 2 diabetes mellitusRandomized controlled trialStudy protocolLow-carbohydrate dietCanagliflozin |
| spellingShingle | Xinyi Xia Miao Xu Yunjie Gu Yangxue Li Li Li Jun Yin Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial Trials Type 2 diabetes mellitus Randomized controlled trial Study protocol Low-carbohydrate diet Canagliflozin |
| title | Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial |
| title_full | Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial |
| title_fullStr | Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial |
| title_full_unstemmed | Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial |
| title_short | Low-carbohydrate diet in the treatment of type 2 diabetes mellitus (LoCaT): study protocol for a multicenter, randomized controlled trial |
| title_sort | low carbohydrate diet in the treatment of type 2 diabetes mellitus locat study protocol for a multicenter randomized controlled trial |
| topic | Type 2 diabetes mellitus Randomized controlled trial Study protocol Low-carbohydrate diet Canagliflozin |
| url | https://doi.org/10.1186/s13063-023-07427-5 |
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