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

项目摘要/摘要 2型糖尿病(T2 DM)是一个主要的公共卫生问题，影响着美国近3000万人和 增加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 还有中风。45%(45%)的糖尿病患者报告说相当大的压力与他们的 糖尿病越来越被认为是血糖控制恶化的关键因素， 2型糖尿病的进展。建议的项目使用基于正念的压力减轻(MBSR)，这是一种强大的 研究良好的基于正念的干预措施，以应对压力作为血糖控制的关键障碍 2型糖尿病患者。这项建议的目标是进行大规模、完全有效的随机对照 确定为期6个月的MBSR干预对患者血糖控制效果的试验(RCT) 伴无节制的T2 DM。我们将290名患有未控制的T2 DM的成年人随机分为6个月的MBSR组 干预或健康教育对照。为期6个月的干预将由加州大学 马萨诸塞州标准的8周MBSR计划，随后是每月MBSR助推会。结果将会 在基线、8周、6个月和12个月时进行评估。具体目标是：1)进行RCT，以 确定为期6个月的MBSR干预与健康教育对290年血糖控制的影响 未控制的T2 DM患者。主要结果将是血红蛋白A1c(HbA1c)，这是一种衡量平均水平的指标 过去3个月的血糖水平。我们假设，在两组人之间，将会有一个临床上的 从基线到第6个月，HbA1c的平均变化绝对差异显著0.5%。此外，我们 将着眼于空腹血糖和血糖变异性，因为它们也与不良结果有关；2) 确定MBSR与健康教育对照对心理社会、行为和生理的影响 在失控的T2 DM患者中潜在的调节降糖作用的机制。主观性 将评估压力、糖尿病相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。未经宣布的电话将被用来获得24小时饮食召回。生理学 检测指标包括血清hsCRP和肿瘤坏死因子-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-淀粉酶检测交感神经系统活性。 这项拟议的研究有可能通过使用一种新的长期护理方案来改变目前的T2 DM护理标准。 将MBSR干预称为对T2 DM的有力辅助干预。MBSR可能会影响临床情况 通过使患者掌握加强自身内部资源的技能来促进自我 调节和适应性应对以及减少应激反应，这些都是实施健康 并有望改善血糖控制，降低糖尿病并发症的风险。 这项提议与国家糖尿病、消化和肾脏研究所的使命有关 疾病研究所(NIDDK)对糖尿病进行研究，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.