Randomized Controlled Trial of a Six-Month Mindfulness-Based Intervention for Type 2 Diabetes

项目总结/摘要 2型糖尿病（T2 DM）是影响美国近3000万人的主要公共卫生问题， 增加了他们患严重并发症的风险，包括失明、截肢、肾衰竭、心脏病发作 和中风。百分之四十五（45%）的糖尿病患者报告与他们的生活有关的相当大的压力。 糖尿病，这是越来越多地被认为是一个关键因素，在恶化葡萄糖控制和 T2 DM的进展。该项目使用基于正念的减压（MBSR），一种强大的， 研究基于正念的干预，以解决压力作为葡萄糖控制的关键障碍， T2 DM患者。本提案的目的是进行一项大规模、全把握度的随机对照研究， 一项旨在明确确定6个月正念减压疗法干预对患者血糖控制效果的随机对照试验（RCT） 不受控制的T2 DM我们将290名未控制的T2 DM成人随机分为6个月的MBSR组 干预或健康教育控制。为期6个月的干预将包括大学 马萨诸塞州标准的8周MBSR计划，然后是每月的MBSR助推器会议。成果将 在基线、8周、6个月和12个月时进行评估。具体目的是：1）进行RCT， 在290名受试者中，确定6个月MBSR干预与健康教育对血糖控制的影响 未控制的T2 DM患者。主要结果将是血红蛋白A1 c（HbA 1c），这是一种衡量平均 过去三个月的血糖水平我们假设，在两组之间，将有一个临床 HbA 1c从基线至第6个月的平均变化的绝对差异显著<0.5%。另外我们 将研究空腹血糖和血糖变异性，因为它们也与不良结局有关; 2） 确定MBSR与健康教育控制对心理社会，行为和生理的影响 可能介导其在不受控制的T2 DM患者中的降糖作用的机制。主观 将评估压力、与糖尿病有关的痛苦和其他心理社会措施。加速度计将是 用于跟踪身体活动。未经通知的电话将用于获得24小时饮食召回。生理 测量包括血清hsCRP和TNF-α作为慢性炎症的标志物，唾液皮质醇评估 下丘脑-垂体-肾上腺轴和唾液α-淀粉酶以评估交感神经系统活性。 这项拟议的研究有可能通过使用一种新的长期- 术语MBSR干预作为T2 DM的有力辅助干预。正念减压疗法可能会影响 2型糖尿病患者通过增强自身内部资源的技能， 调节和适应性应对，减少压力反应，这些都是实施健康 行为和预期导致改善血糖控制和降低糖尿病并发症的风险。 这项建议与国家糖尿病、消化和肾脏研究所的使命有关 疾病（NIDDK）进行糖尿病研究，以改善人们的健康和生活质量。

Project Summary/Abstract Type 2 diabetes (T2DM) is a major public health concern affecting nearly 30 million people in the U.S. and increasing their risk for serious complications including blindness, amputations, kidney failure, heart attacks and strokes. Forty five percent (45%) of people with diabetes report considerable stress related to their diabetes, which is increasingly being recognized as a key factor in worsening glucose control and the progression of T2DM. The proposed project uses mindfulness-based stress reduction (MBSR), a powerful and well researched mindfulness-based intervention, to address stress as a critical barrier to glucose control in patients with T2DM. The objective of this proposal is to conduct a large, fully-powered randomized controlled trial (RCT) to definitively determine the effects of a 6-month MBSR intervention on glucose control in patients with uncontrolled T2DM. We will randomize 290 adults with uncontrolled T2DM to a 6-month MBSR intervention or health education control. The 6-month intervention will consist of the University of Massachusetts standard 8-week MBSR program followed by monthly MBSR booster sessions. Outcomes will be assessed at baseline, 8-weeks, 6 months and 12 months. Specific Aims are: 1) To conduct a RCT to determine the effects of a 6-month MBSR intervention compared to health education on glucose control in 290 patients with uncontrolled T2DM. The primary outcome will be hemoglobin A1c (HbA1c), a measure of average glucose levels over the past 3 months. We hypothesize that between the two groups, there will be a clinically significant 0.5% absolute difference in the mean change in HbA1c from baseline to month 6. Additionally, we will look at fasting glucose and glucose variability as they are also linked with adverse outcomes; 2) To determine the effects of MBSR versus health education control on psychosocial, behavioral and physiological mechanisms potentially mediating its glucose-lowering effects in patients with uncontrolled T2DM. Subjective stress, diabetes-related distress and other psychosocial measures will be assessed. Accelerometry will be used to track physical activity. Unannounced phone calls will be used to obtain 24 hour diet recalls. Physiologic measures include serum hsCRP and TNF-α as markers of chronic inflammation, salivary cortisol to assess the hypothalamic-pituitary-adrenal axis, and salivary α-amylase to assess sympathetic nervous system activity. The proposed study has the potential to transform current standards of care for T2DM by using a novel long- term MBSR intervention as a powerful adjunct intervention for T2DM. MBSR could impact the clinical picture of T2DM by empowering patients with skills for strengthening their own internal resources to promote self- regulation and adaptive coping and reduce stress reactivity, which are all essential for implementing healthy behaviors and are expected to lead to improved glucose control and reduced risk of diabetes complications. This proposal is relevant to the mission of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) to conduct research on diabetes to improve people's health and quality of life.