Emotional Distress in a Comparative Effectiveness Trial of Diabetes Treatments

 描述(申请人提供)：情绪困扰，包括抑郁和糖尿病特有的痛苦(例如，与糖尿病生活有关的不堪重负的感觉，与糖尿病自我护理有关的失败感)，是2型糖尿病患者普遍存在的重大问题。抑郁和糖尿病困扰都与代谢/血糖控制、糖尿病并发症、死亡率和生活质量有关。最近的研究结果进一步表明，糖尿病治疗会影响情绪困扰的风险。GRADE研究(糖尿病中降低血糖的方法：一项比较有效性研究)正在产生前瞻性数据，这些数据将提供一个独特的机会，在实验设计中检查情绪困扰、糖尿病治疗和结果之间的关系。GRADE研究是一项随机临床试验，将比较四种常见抗糖尿病药物与二甲双胍联合使用时的代谢效果。这项子研究将招募总共2500名患者，他们在确诊后10年内，在登记时正在接受二甲双胍单一疗法治疗。这项研究将检查基线情绪困扰患者水平的变化，将其作为血糖控制和其他健康结果的预测因子，与治疗效果无关。这项研究还将对治疗方案随时间推移对情绪困扰的影响进行严格的实验检查，作为

 DESCRIPTION (provided by applicant): Emotional distress, including depression and diabetes-specific distress (e.g., feeling overwhelmed by living with diabetes, feelings of failure related to diabetes self-care), is a significant and prevalent problem for patients with type 2 diabetes. Both depression and diabetes distress have been associated with metabolic/glycemic control, diabetes complications, mortality, and quality of life. Recent findings further suggest tht risk for emotional distress is influenced by diabetes treatment. The GRADE study (Glycemia Reduction Approaches in Diabetes: A Comparative Effectiveness Study) is generating prospective data that will provide a unique opportunity to examine the relationships between emotional distress, diabetes treatment, and outcomes in an experimental design. The GRADE study is a randomized clinical trial that will compare the metabolic effects of four common anti-diabetic drugs when combined with metformin. This sub- study will recruit a total of 2,500 patients who are within 10 years of diagnosis and are being treated with metformin monotherapy at the time of enrollment. The study will examine patient-level variation in baseline emotional distress as a predictor of glycemic control and other health outcomes, independent of treatment effects. The study will also provide a rigorous experimental examination of treatment regimen effects on emotional distress over time as part of the