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首页> 外文期刊>BMJ Open >Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)
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Rationale, design and study protocol of the randomised controlled trial: Diabetes Interventional Assessment of Slimming or Training tO Lessen Inconspicuous Cardiovascular Dysfunction (the DIASTOLIC study)

机译:随机对照试验的原理,设计和研究方案:减肥或培训的糖尿病干预评估可减轻不起眼的心血管功能障碍(DIASTOLIC研究)

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Introduction Despite their young age and relatively short duration of disease, younger adults with type 2 diabetes (T2D) already have diastolic dysfunction and may be at risk of incipient heart failure. Whether weight loss or exercise training improve cardiac dysfunction in people with T2D remains to be established.Methods and analysis Prospective, randomised, open-label, blind endpoint trial. The primary aim of the study is to determine if diastolic function can be improved by either a meal replacement plan or a supervised exercise programme, compared with guideline-directed care. A total of 90 obese participants with T2D (aged 18–65 years), diabetes duration 12 years and not on insulin treatment will be randomised to either guideline-directed clinical care with lifestyle coaching, a low-energy meal replacement diet (average ≈810 kcal/day) or a supervised exercise programme for 12?weeks. Participants undergo glycometabolic profiling, cardiopulmonary exercise testing, echocardiography and MRI scanning to assesses cardiac structure and function and dual-energy X-ray absorptiometry scanning for body composition. Key secondary aims are to assess the effects of the interventions on glycaemic control and insulin resistance, exercise capacity, blood pressure, changes in body composition and association of favourable cardiac remodelling with improvements in weight loss, exercise capacity and glycometabolic control.Ethics and dissemination The study has full ethical approval, and data collection was completed in August 2018. The study results will be submitted for publication within 6?months of completion.Trial registration number NCT02590822; Pre-results.
机译:简介尽管年龄较小且疾病持续时间相对较短,但患有2型糖尿病(T2D)的年轻成年人已经患有舒张功能障碍,并可能有初期心力衰竭的风险。减肥或运动训练是否可以改善T2D患者的心脏功能障碍尚待确定。方法与分析前瞻性,随机,开放标签,盲目的试验。这项研究的主要目的是确定与指导性护理相比,代餐计划或有监督的运动计划是否可以改善舒张功能。总共90名2型糖尿病(18-65岁),糖尿病病程<12年且未接受胰岛素治疗的肥胖参与者将被随机分配到以生活方式指导,低能量餐替代饮食的指导性临床护理(平均810大卡/天)或为期12周的监督运动计划。参加者进行糖代谢谱分析,心肺运动测试,超声心动图和MRI扫描,以评估心脏的结构和功能,以及双能X线吸收仪扫描身体成分。主要的次要目的是评估干预措施对血糖控制和胰岛素抵抗,运动能力,血压,身体成分的变化以及良好的心脏重塑与体重减轻,运动能力和糖代谢控制的改善之间的关系。研究已获得伦理学完全批准,数据收集于2018年8月完成。研究结果将在完成后的6个月内提交发表。试验注册号为NCT02590822;结果。

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