MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK
MRC Epidemiology Unit, University of Cambridge School of Clinical Medicine, Cambridge, Cambridgeshire, UK.
BMJ Open. 2020 Apr 28;10(4):e035020. doi: 10.1136/bmjopen-2019-035020.
People with type 2 diabetes (T2D) can improve glycaemic control or even achieve remission through weight loss and reduce their use of medication and risk of cardiovascular disease. The Glucose Lowering through Weight management (GLoW) trial will evaluate whether a tailored diabetes education and behavioural weight management programme (DEW) is more effective and cost-effective than a diabetes education (DE) programme in helping people with overweight or obesity and a recent diagnosis of T2D to lower their blood glucose, lose weight and improve other markers of cardiovascular risk.
This study is a pragmatic, randomised, single-blind, parallel group, two-arm, superiority trial. We will recruit 576 adults with body mass index>25 kg/m and diagnosis of T2D in the past 3 years and randomise them to a tailored DEW or a DE programme. Participants will attend measurement appointments at a local general practitioner practice or research centre at baseline, 6 and 12 months. The primary outcome is 12-month change in glycated haemoglobin. The effect of the intervention on the primary outcome will be estimated and tested using a linear regression model (analysis of covariance) including randomisation group and adjusted for baseline value of the outcome and the randomisation stratifiers. Participants will be included in the group to which they were randomised, under the intention-to-treat principle. Secondary outcomes include 6-month and 12-month changes in body weight, body fat percentage, systolic and diastolic blood pressure and lipid profile; probability of achieving good glycaemic control; probability of achieving remission from diabetes; probability of losing 5% and 10% body weight and modelled cardiovascular risk (UKPDS). An intention-to-treat within-trial cost-effectiveness analysis will be conducted from NHS and societal perspectives using participant-level data. Qualitative interviews will be conducted with participants to understand why and how the programme achieved its results and how participants manage their weight after the programme ends.
Ethical approval was received from East of Scotland Research Ethics Service on 15 May 2018 (18/ES/0048). This protocol (V.3) was approved on 19 June 2019. Findings will be published in peer-reviewed scientific journals and communicated to other stakeholders as appropriate.
ISRCTN18399564.
2 型糖尿病（T2D）患者可通过减轻体重来改善血糖控制水平，甚至实现缓解，同时减少药物使用并降低心血管疾病风险。通过体重管理降低血糖（GLoW）试验将评估针对超重或肥胖且近期被诊断患有 T2D 的患者，量身定制的糖尿病教育和行为体重管理方案（DEW）是否比糖尿病教育（DE）方案更有效和更具成本效益，以帮助他们降低血糖、减轻体重并改善其他心血管风险标志物。
这是一项实用、随机、单盲、平行分组、双臂、优效性试验。我们将招募 576 名身体质量指数（BMI）>25kg/m 和在过去 3 年内被诊断患有 T2D 的成年人，并将他们随机分配到量身定制的 DEW 或 DE 方案组。参与者将在基线、6 个月和 12 个月在当地全科医生诊所或研究中心进行测量预约。主要结局为 12 个月时糖化血红蛋白的变化。干预对主要结局的影响将使用线性回归模型（协方差分析）进行估计和检验，该模型包括随机分组和调整结局的基线值以及随机分组分层因素。根据意向治疗原则，参与者将被纳入他们被随机分配到的组中。次要结局包括体重、体脂百分比、收缩压和舒张压以及血脂谱在 6 个月和 12 个月时的变化；实现良好血糖控制的概率；糖尿病缓解的概率；体重减轻 5%和 10%的概率以及模型化的心血管风险（UKPDS）。将从英国国家医疗服务体系和社会角度，使用参与者水平数据进行意向治疗内试验成本效益分析。将对参与者进行定性访谈，以了解方案如何实现其结果，以及参与者在方案结束后如何管理体重。
2018 年 5 月 15 日，东苏格兰研究伦理服务机构（East of Scotland Research Ethics Service）批准了这项研究（18/ES/0048）。2019 年 6 月 19 日批准了本研究方案（第 3 版）。研究结果将发表在同行评议的科学期刊上，并酌情传达给其他利益相关者。
ISRCTN86671544。
