Comparing Two Dietary Approaches for Type 2 Diabetes

比较 2 型糖尿病的两种饮食方法

• 批准号: 10437898
• 负责人: Laura Saslow
• 金额: $ 68.28万
• 依托单位: UNIVERSITY OF MICHIGAN AT ANN ARBOR
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-07-01 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10437898
• 关键词: Address; Adherence; Adult; Adverse effects; American; Area; Behavioral; Body Composition; Body mass index; Bone Density; C-reactive protein; Carbohydrates; Chronic Disease; Clinical; Constipation; Consumption; Diabetes Mellitus; Diabetic Diet; Diet; Dietary Intervention; Distress; Eating; Glycosylated hemoglobin A; Headache; Individual; Inflammation; Insulin Resistance; Intake; Knowledge; Lipids; Long-Term Effects; Macronutrients Nutrition; Measures; Medical; Meta-Analysis; Methods; Monitor; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Outcome; Pharmaceutical Preparations; Practice Guidelines; Randomized; Recommendation; Research; Review Committee; Site; Social support; Testing; Therapeutic Intervention; Weight; behavior test; cost; dietary; dietary approach; disorder later incidence prevention; evidence base; follow-up; fruits and vegetables; glycemic control; healthy lifestyle; improved; interest; nutrition; nutritional guideline; physical conditioning; prevent; primary outcome; sex; side effect; treatment arm; treatment guidelines

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.

抽象的 2型糖尿病是美国2型糖尿病营养管理中最昂贵的慢性疾病 有可能改善血糖控制和临床结果，副作用较少，成本较低 比密集的医疗管理。但是，我们远没有完全意识到营养的潜力 管理以改善糖尿病结果。一个重要的限制是缺乏高质量的研究。最后的 年，美国糖尿病协会（ADA）营养审查委员会（PI服务） 总结说：“尽管对基于证据的糖尿病营养疗法干预措施的兴趣广泛，但 经过良好的营养试验继续远远落后于其他糖尿病研究领域。 解决我们知识中的关键差距，以告知临床指南2型营养管理 关于大量营养素含量的糖尿病。一些证据表明，减少了总碳水化合物的摄入量 与饮食计划相比 碳含含量。但是，关键知识差距阻止明确的建议：1） 关于血糖控制中收益的耐用性的知识，2）关注可能的长期对立 效果，以及3）尽管当前的建议提出了有关个体化建议 碳水化合物含量，我们几乎不知道指导这一点。为了解决这些差距，我们提出了两个 位点，平行组，随机（1：1）试验，在180名2型糖尿病的成年人中进行了12个月的随访， 将非常低碳水化合物的饮食与现代碳水化合物使用饮食进行比较 - 由ADA推荐。两组将被教授先前测试的行为策略以维护 遵守营养治疗。目标1：比较两种饮食对测量的长期影响 身体健康：血糖控制（HBA1C，主要结局），体重，炎症（C反应蛋白），能够 减少使用糖尿病药物和与药物相关的成本的使用，以及12岁以上的糖尿病药物相关困扰 月份。我们假设非常低碳水化合物的饮食组（与中度相比 碳水化合物饮食组）将在12个月时具有较低的HBA1C和其他结果的改善。目标2： 比较不良影响。目标3：评估识别个人会特别受益的因素 营养干预臂，包括胰岛素抵抗，体重指数和性别。拟议的研究 将解决2型糖尿病营养管理的证据基础中的重要差距，并具有 加强基于证据的方法来改善2型糖尿病结局的潜力。