Medication following bariatric surgery for type 2 diabetes mellitus (BY-PLUS) study: rationale and design of a randomised controlled study

Alexis Sudlow, Alexander Dimitri Miras, Ricardo Vitor Cohen, Hassan Kahal, Jill Townley, Helen Heneghan, Carel Le Roux, Dimitri J Pournaras

Research output: Contribution to journalArticlepeer-review

Abstract

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
Original languageEnglish
Article numbere054313
Pages (from-to)1-10
Number of pages10
JournalBMJ Open
Volume12
Issue number7
Early online date25 Jul 2022
DOIs
Publication statusE-pub ahead of print - 25 Jul 2022

Keywords

  • Diabetes and endocrinology
  • 1506
  • 1843
  • DIABETES & ENDOCRINOLOGY
  • General diabetes
  • SURGERY

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