Comparing Two Dietary Approaches for Type 2 Diabetes

摘要 2型糖尿病是美国最昂贵的慢性疾病。2型糖尿病的营养管理 具有改善血糖控制和临床结果的潜力，副作用少，成本低 比密集的医疗管理。然而，我们还远远没有充分认识到营养的潜力。 管理，以改善糖尿病的结果。一个重要的限制是缺乏高质量的研究。最后 2009年，美国糖尿病协会（ADA）营养审查委员会（PI担任该委员会成员） 结论是：“尽管人们对循证糖尿病营养治疗干预措施普遍感兴趣， 进行良好的营养试验仍然远远落后于糖尿病研究的其他领域。这项建议 解决了我们知识的关键差距，为2型糖尿病的营养管理提供临床指南 糖尿病与宏量营养素含量有关。一些证据表明，减少碳水化合物的总摄入量 与碳水化合物含量更高的饮食计划相比， 碳水化合物含量然而，关键的知识差距阻碍了明确的建议：1） 关于血糖控制增益持久性的知识，2）对可能的长期不良反应的担忧 影响，以及，3）虽然目前的建议，建议个性化的建议， 碳水化合物的含量，我们几乎没有知识来指导这一点。为了解决这些问题，我们提出了两个- 在180名2型糖尿病成人患者中进行的一项12个月随访的现场、平行组、随机（1：1）试验， 将非常低碳水化合物的饮食与中等碳水化合物的饮食进行比较， 由ADA推荐。两组都将被教授先前测试过的行为策略， 坚持营养治疗。目的1：比较两种饮食对以下指标的长期影响： 身体健康：血糖控制（HbA 1c，主要结局）、体重、炎症（C反应蛋白）、 减少糖尿病药物的使用和药物相关的费用，以及12岁以上糖尿病相关的痛苦 个月我们假设，非常低碳水化合物饮食组（与中等碳水化合物饮食组相比， 碳水化合物饮食组）将在12个月时降低HbA 1c并改善其他结局。目标二： 比较不良影响。目标3：评估确定哪些人将特别受益于一项活动的因素 包括胰岛素抵抗、体重指数和性别。拟定研究 将解决2型糖尿病营养管理证据基础中的重要空白， 加强循证方法以改善2型糖尿病结局的潜力。

ABSTRACT Type 2 diabetes is the most expensive chronic disease in the U.S. Nutritional management of type 2 diabetes has the potential to improve glycemic control and clinical outcomes with fewer side effects and lower costs than intensive medical management. However, we are far from fully realizing the potential of nutritional management to improve diabetes outcomes. One important limitation is the lack of high-quality research. Last year, the American Diabetes Association’s (ADA’s) Nutrition Review Committee (on which the PI served) concluded that: “Despite widespread interest in evidence-based diabetes nutrition therapy interventions, large, well-conducted nutrition trials continue to lag far behind other areas of diabetes research.” This proposal addresses critical gaps in our knowledge to inform clinical guidelines for the nutritional management of type 2 diabetes in regard to macronutrient content. Some evidence indicates that reducing overall carbohydrate intake with a very low-carbohydrate eating plan can improve glycemic control compared to eating plans with greater carbohydrate content. However, critical knowledge gaps prevent clear recommendations: 1) a gap in knowledge about the durability of gains in glycemic control, 2) concerns about possible long-term adverse effects, and, 3) although current recommendations suggest individualizing recommendations about carbohydrate content, we have almost no knowledge to guide this. To address these gaps, we propose a two- site, parallel-group, randomized (1:1) trial with a 12-month follow-up in 180 adults with type 2 diabetes, comparing a very low-carbohydrate diet to a moderate-carbohydrate plate-method diet—both are approaches recommended by the ADA. Both groups will be taught previously tested behavioral strategies to maintain adherence to nutritional treatment. Aim 1: Compare the long-term effects of the two diets on measures of physical health: glycemic control (HbA1c, primary outcome), weight, inflammation (C-reactive protein), ability to reduce the use of diabetes medications and medication-related costs, and diabetes-related distress over 12 months. We hypothesize that the very low-carbohydrate diet group (as compared to the moderate- carbohydrate diet group) will have lower HbA1c and improvements in other outcomes at 12 months. Aim 2: Compare adverse effects. Aim 3: Assess factors that identify individuals who will particularly benefit from one of the nutritional intervention arms, including insulin resistance, body mass index, and sex. The proposed study will address important gaps in the evidence base for the nutritional management of type 2 diabetes and has the potential to strengthen evidence-based approaches to improve type 2 diabetes outcomes.