Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study
Introduction Bariatric surgery is an effective method of controlling glycaemia in patients with type 2 diabetes mellitus (T2DM) and obesity. Long-term studies suggest that although glycaemic control remains good, only 20%–40% of patients will maintain remission according to the American Diabetes Ass...
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BMJ Publishing Group
2022-07-01
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| Series: | BMJ Open |
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| author | Alexander Dimitri Miras Carel le Roux Alexis Sudlow Ricardo Vitor Cohen Hassan Kahal Dimitri J Pournaras Jill Townley Helen Heneghan |
| author_facet | Alexander Dimitri Miras Carel le Roux Alexis Sudlow Ricardo Vitor Cohen Hassan Kahal Dimitri J Pournaras Jill Townley Helen Heneghan |
| author_sort | Alexander Dimitri Miras |
| collection | DOAJ |
| description | Introduction Bariatric surgery is an effective method of controlling glycaemia in patients with type 2 diabetes mellitus (T2DM) and obesity. Long-term studies suggest that although glycaemic control remains good, only 20%–40% of patients will maintain remission according to the American Diabetes Association criteria.Purpose This trial aims to examine the safety and efficacy of combining Roux-en-Y gastric bypass or sleeve gastrectomy with goal-directed medical therapy to improve long-term glycaemic control of T2DM.Methods and analysis This prospective, open-label multicentre randomised controlled trial (RCT) will recruit 150 patients with obesity and T2DM from tertiary care obesity centres. Patients will be randomised 1:1 to receive either bariatric surgery and standard medical care or bariatric surgery and intensive goal-directed medical therapy, titrated to specific targets for glycated haemoglobin (HbA1c), blood pressure (BP) and low-density lipoproteins (LDL) cholesterol. The primary endpoints are the proportion of patients in each arm with an HbA1c<6.5% (48 mmol/mol) at 1 year and the proportion of patients in each arm achieving the composite endpoint of HbA1c<6.5% (48 mmol/mol), BP<130/80 mm Hg and LDL<2.6 mmol/L at 5 years.Ethics and dissemination The local institutional review board approved this study. This study represents the first RCT to examine the safety and efficacy of combining bariatric surgery with intensive medical therapy compared with bariatric surgery and usual care for long-term diabetes control.Trial registration number NCT04432025. |
| format | Article |
| id | doaj-art-74761503003b4b1c8edbb7b87dd44ac3 |
| institution | Kabale University |
| issn | 2044-6055 |
| language | English |
| publishDate | 2022-07-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj-art-74761503003b4b1c8edbb7b87dd44ac32025-01-31T02:30:10ZengBMJ Publishing GroupBMJ Open2044-60552022-07-0112710.1136/bmjopen-2021-054313Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled studyAlexander Dimitri Miras0Carel le Roux1Alexis Sudlow2Ricardo Vitor Cohen3Hassan Kahal4Dimitri J Pournaras5Jill Townley6Helen Heneghan7School of Medicine, Ulster University, Londonderry, UK2 University College Dublin, Dublin, IrelandDepartment of Upper GI and Bariatric Surgery, Southmead Hospital, Bristol, UKThe Center for Obesity and Diabetes, Hospital Alemao Oswaldo Cruz, Sao Paulo, BrazilDepartment of Diabetes and Endocrinology, Southmead Hospital, Bristol, UKDepartment of Upper Gastrointestinal Surgery, Southmead Hospital, Bristol, UKDepartment of Surgery, Southmead Hospital, Bristol, UKDepartment of Surgery, St Vincent`s University Hospital, Dublin, IrelandIntroduction Bariatric surgery is an effective method of controlling glycaemia in patients with type 2 diabetes mellitus (T2DM) and obesity. Long-term studies suggest that although glycaemic control remains good, only 20%–40% of patients will maintain remission according to the American Diabetes Association criteria.Purpose This trial aims to examine the safety and efficacy of combining Roux-en-Y gastric bypass or sleeve gastrectomy with goal-directed medical therapy to improve long-term glycaemic control of T2DM.Methods and analysis This prospective, open-label multicentre randomised controlled trial (RCT) will recruit 150 patients with obesity and T2DM from tertiary care obesity centres. Patients will be randomised 1:1 to receive either bariatric surgery and standard medical care or bariatric surgery and intensive goal-directed medical therapy, titrated to specific targets for glycated haemoglobin (HbA1c), blood pressure (BP) and low-density lipoproteins (LDL) cholesterol. The primary endpoints are the proportion of patients in each arm with an HbA1c<6.5% (48 mmol/mol) at 1 year and the proportion of patients in each arm achieving the composite endpoint of HbA1c<6.5% (48 mmol/mol), BP<130/80 mm Hg and LDL<2.6 mmol/L at 5 years.Ethics and dissemination The local institutional review board approved this study. This study represents the first RCT to examine the safety and efficacy of combining bariatric surgery with intensive medical therapy compared with bariatric surgery and usual care for long-term diabetes control.Trial registration number NCT04432025.https://bmjopen.bmj.com/content/12/7/e054313.full |
| spellingShingle | Alexander Dimitri Miras Carel le Roux Alexis Sudlow Ricardo Vitor Cohen Hassan Kahal Dimitri J Pournaras Jill Townley Helen Heneghan Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study BMJ Open |
| title | Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study |
| title_full | Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study |
| title_fullStr | Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study |
| title_full_unstemmed | Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study |
| title_short | Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study |
| title_sort | medication following bariatric surgery for type 2 diabetes mellitus by plus study rationale and design of a randomised controlled study |
| url | https://bmjopen.bmj.com/content/12/7/e054313.full |
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