Clinical and Experimental Medicine, University of Birmingham, Birmingham, UK.
Trials. 2013 Jun 18;14:180. doi: 10.1186/1745-6215-14-180.
Exercise has a beta cell preserving effect in patients with type 2 diabetes. This benefit of exercise has not been examined in type 1 diabetes. Significant beta cell function is present at the time of diagnosis of type 1 diabetes and therefore studies of beta cell preservation are ideally conducted immediately after diagnosis.Many of the variables required to design and power such a study are currently unknown. The aim of EXTOD is to obtain the information required to design a formal study of exercise and beta cell preservation in newly diagnosed patients with type 1 diabetes.
Barriers to exercise will initially be assessed in a qualitative study of newly diagnosed patients. Then, sixty newly diagnosed adult type 1 diabetes patients will be randomized to either conventional treatment or exercise, stratified on beta cell function and fitness. The exercise group will be encouraged to increase their level of activity to a minimum of 150 minutes of moderate to vigorous intensity exercise per week, aiming for 240 minutes per week of exercise for 12 months. Beta cell function will be measured by meal-stimulated C peptide. Primary outcomes are recruitment, adherence to exercise, loss to follow-up, and exercise levels in the non-intervention arm (contamination). The secondary outcome of the study is rate of loss of beta cell function.
The outcomes of the EXTOD study will help define the barriers, uptake and benefits of exercise in adults newly diagnosed with type 1 diabetes. This information will enable design of a formal study to assess the effect of exercise on beta cell preservation in newly diagnosed patients with type 1 diabetes.
Current controlled trials ISRCTN91388505.
运动对 2 型糖尿病患者的胰岛β细胞具有保护作用。这种运动的益处尚未在 1 型糖尿病患者中进行过研究。1 型糖尿病诊断时β细胞功能仍显著存在，因此β细胞保护的研究理想情况下应在诊断后立即进行。目前许多设计和实施此类研究所需的变量尚不清楚。EXTOD 的目的是获得设计 1 型糖尿病新诊断患者运动和β细胞保护的正式研究所需的信息。
首先，对新诊断的患者进行定性研究，评估运动的障碍。然后，将 60 名新诊断的成年 1 型糖尿病患者随机分为常规治疗组或运动组，根据β细胞功能和健康状况进行分层。鼓励运动组将其活动水平提高到每周至少 150 分钟中等至剧烈强度的运动，目标是每周进行 240 分钟的运动，持续 12 个月。β细胞功能将通过餐刺激 C 肽进行测量。主要结局是招募、坚持运动、随访丢失和非干预组（污染）的运动水平。研究的次要结局是β细胞功能丧失率。
EXTOD 研究的结果将有助于确定新诊断为 1 型糖尿病的成年人运动的障碍、参与度和益处。这些信息将使设计一项正式研究能够评估运动对新诊断的 1 型糖尿病患者β细胞保护的影响。
当前对照试验 ISRCTN91388505。
