Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial
Head-to-head comparison of intensive lifestyle intervention (U-TURN) versus conventional multifactorial care in patients with type 2 diabetes: protocol and rationale for an assessor-blinded, parallel group and randomised trial
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DOI：
10.1136/bmjopen-2015-009764
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发表时间：
2015-01-01
期刊：
影响因子：
2.9
通讯作者：
Karstoft, Kristian
中科院分区：
文献类型：
--
作者：
Ried-Larsen, Mathias;Christensen, Robin;Karstoft, Kristian
目前2型糖尿病（T2D）患者的药物治疗由于缺乏可持续性和真正长期健康益处的边缘性确凿证据而受到挑战。因此，生活方式干预仍然是t2dm治疗的基石。然而，缺乏关于t2dm最佳干预方案的知识，以确保依从性和长期健康结果。我们的目的是评估强化生活方式干预（U-TURN干预）对t2dm患者血糖控制的影响。我们的假设是，密集的生活方式改变与标准的糖尿病治疗一样有效，包括维持t2dm患者血糖控制（即糖化血红蛋白（HbA1c））的药物治疗。此外，我们预计密集的生活方式改变将减少对抗糖尿病药物的需求。该研究采用评估盲、平行组和1年随机试验。主要结局是血糖控制（HbA1c）的改变，关键的次要结局是抗糖尿病药物的减少。参与者为T2D患者（T2D持续时间）
Introduction Current pharmacological therapies in patients with type 2 diabetes (T2D) are challenged by lack of sustainability and borderline firm evidence of real long-term health benefits. Accordingly, lifestyle intervention remains the corner stone in the management of T2D. However, there is a lack of knowledge regarding the optimal intervention programmes in T2D ensuring both compliance as well as long-term health outcomes. Our objective is to assess the effects of an intensive lifestyle intervention (the U-TURN intervention) on glycaemic control in patients with T2D. Our hypothesis is that intensive lifestyle changes are equally effective as standard diabetes care, including pharmacological treatment in maintaining glycaemic control (ie, glycated haemoglobin (HbA1c)) in patients with T2D. Furthermore, we expect that intensive lifestyle changes will decrease the need for antidiabetic medications.Methods and analysis The study is an assessor-blinded, parallel group and a 1-year randomised trial. The primary outcome is change in glycaemic control (HbA1c), with the key secondary outcome being reductions in antidiabetic medication. Participants will be patients with T2D (T2D duration