减重手术后治疗 2 型糖尿病（BY-PLUS）研究中的药物治疗：一项随机对照研究的原理和设计。

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

机构信息

Department of Upper GI and Bariatric Surgery, Southmead Hospital, Bristol, UK

School of Medicine, Ulster University, Londonderry, UK.

出版信息

BMJ Open. 2022 Jul 25;12(7):e054313. doi: 10.1136/bmjopen-2021-054313.

DOI:10.1136/bmjopen-2021-054313

PMID:35879015

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9328090/

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<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.

摘要

简介

减重手术是控制 2 型糖尿病（T2DM）和肥胖患者血糖的有效方法。长期研究表明，尽管血糖控制仍然良好，但只有 20%-40%的患者根据美国糖尿病协会的标准维持缓解。

目的

本试验旨在研究罗伊氏胃旁路术或袖状胃切除术联合目标导向的药物治疗对改善 T2DM 患者长期血糖控制的安全性和有效性。

方法和分析

这是一项前瞻性、开放标签、多中心随机对照试验（RCT），将从三级肥胖治疗中心招募 150 名肥胖和 T2DM 患者。患者将以 1:1 的比例随机接受减重手术和标准药物治疗或减重手术和强化目标导向的药物治疗，将糖化血红蛋白（HbA1c）、血压（BP）和低密度脂蛋白（LDL）胆固醇的特定目标进行滴定。主要终点是在 1 年时每个治疗组中 HbA1c<6.5%（48 mmol/mol）的患者比例，以及每个治疗组中达到 HbA1c<6.5%（48 mmol/mol）、BP<130/80 mmHg 和 LDL<2.6 mmol/L 的复合终点的患者比例。