达格列净联合运动训练对 2 型糖尿病成人患者身体机能的影响：达格列净、运动训练和身体机能（DETA）随机对照试验研究方案。
Impact of exercise training in combination with dapagliflozin on physical function in adults with type 2 diabetes mellitus: study protocol for the Dapagliflozin, Exercise Training and physicAl function (DETA) randomised controlled trial.
机构信息
Leicester Diabetes Centre, University Hospitals of Leicester NHS Trust, Leicester, UK
NIHR Leicester Biomedical Research Centre, Leicester, UK.
出版信息
BMJ Open. 2024 Nov 25;14(11):e084482. doi: 10.1136/bmjopen-2024-084482.
INTRODUCTION
Sodium-glucose co-transporter 2 inhibitors (SGLT2i) are associated with weight loss, diverse cardiorenal benefits and improved glycaemic control. However, the effects of SGLT2i on physical function and fitness are uncertain. The Dapagliflozin, Exercise Training and physicAl function trial investigates whether the SGLT2i dapagliflozin, alone or in combination with structured exercise training, improves physical function compared with diet-induced weight loss in adults with type 2 diabetes mellitus (T2DM), overweight/obesity and impaired physical function.
METHODS AND ANALYSIS
This single-centre randomised controlled trial will assign 1:1:1, 135 adults with T2DM and low physical function to receive one of three treatments: (1) dapagliflozin (10 mg once-daily) alone, (2) dapagliflozin (10 mg once-daily) plus structured exercise training or (3) diet control (where participants are supported to achieve 3% weight loss, equivalent to estimated weight loss with dapagliflozin treatment). Primary and secondary outcomes will be assessed at baseline, 12 and 24 weeks. The primary outcome is the difference in physical function, assessed using the modified Physical Performance Test, between the treatment groups and diet control at 24 weeks. Secondary outcomes include MRI-measured cardiac structure and function, maximal aerobic capacity, resting metabolic rate, device-measured physical activity and sleep, body composition, haemoglobin A1c and cardiovascular risk markers.
ETHICS AND DISSEMINATION
The Heath Research Authority (HRA) and the Medicines and Healthcare Products Regulatory Authority (MHRA) Research Ethics Committee have approved the study. The findings of the study will be published in peer-reviewed journals.
TRIAL REGISTRATION NUMBER
ISRCTN11459997.
EUDRACT NUMBER
2019-004586-41.
简介
钠-葡萄糖协同转运蛋白 2 抑制剂（SGLT2i）可减轻体重，带来多样化的心肾获益，并改善血糖控制。然而，SGLT2i 对身体机能和健康的影响尚不确定。达格列净、运动训练和身体机能试验旨在研究 SGLT2 抑制剂达格列净，单独或与结构化运动训练联合应用，与饮食诱导的体重减轻相比，是否能改善 2 型糖尿病（T2DM）、超重/肥胖和身体机能受损成人的身体机能。
方法和分析
这项单中心随机对照试验将以 1:1:1 的比例，将 135 名 T2DM 合并低身体机能的成年人随机分至以下 3 种治疗组之一：（1）达格列净（10mg，每日 1 次）单药治疗，（2）达格列净（10mg，每日 1 次）联合结构化运动训练，或（3）饮食控制（支持患者减轻 3%的体重，相当于达格列净治疗的预计体重减轻量）。主要和次要结局将在基线、12 周和 24 周进行评估。主要结局是 24 周时，治疗组与饮食控制组之间的身体机能差异，使用改良的体力活动测试评估。次要结局包括心脏结构和功能的 MRI 测量、最大有氧能力、静息代谢率、设备测量的身体活动和睡眠、身体成分、糖化血红蛋白和心血管风险标志物。
伦理和传播
英国健康研究机构（HRA）和英国药品和保健品管理局（MHRA）研究伦理委员会已批准了该研究。研究结果将发表在同行评议的期刊上。
试验注册号
ISRCTN80040513。
欧洲药品管理局注册号
2019-004586-41。
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