Testing a very low-carbohydrate diet version of the Diabetes Prevention Program to reduce risk factors for type 2 diabetes

测试极低碳水化合物饮食版本的糖尿病预防计划，以减少 2 型糖尿病的危险因素

• 批准号: 10468043
• 负责人: Laura Saslow
• 金额: $ 58.94万
• 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: 2021-08-15 至 2026-04-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10468043
• 关键词: Adult; American; Amputation; Blindness; Body Weight; Body Weight decreased; Body fat; COVID-19 mortality; Caloric Restriction; Carbohydrates; Centers for Disease Control and Prevention (U.S.); Clinical Trials; Communities; Country; Diabetes Mellitus; Diabetes prevention; Diet; Dietary Practices; Disease; Educational Curriculum; Effectiveness; Fatty acid glycerol esters; Foundations; Glycosylated hemoglobin A; Goals; Health; Hypoglycemic Agents; Incidence; Individual; Inflammation; Intake; Intervention; Kidney; Lead; Life Style; Measures; Medicare; Methods; Michigan; Mission; Myocardial Infarction; National Institute of Diabetes and Digestive and Kidney Diseases; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Outcome; Overweight; Participant; Persons; Pharmaceutical Preparations; Physical activity; Population; Prediabetes syndrome; Prevalence; Prevention strategy; Principal Investigator; Public Health; Randomized; Randomized Controlled Trials; Research; Research Personnel; Resources; Review Committee; Risk; Risk Factors; Risk Reduction; Site; Stroke; Testing; United States; Weight; Work; adult obesity; arm; base; clinical practice; design; diabetes prevention program; diabetes risk; dietary; dietary adherence; dietary restriction; effectiveness testing; efficacy testing; evidence base; follow up assessment; glycemic control; high risk; improved; multi-site trial; nutrition; personalized intervention; pilot test; preservation; prevent; primary outcome; programs; randomized trial; response; secondary outcome; tool; treatment as usual

ABSTRACT One-third of U.S. adults have prediabetes and are at high risk of developing type 2 diabetes and its devastating health consequences. The landmark Diabetes Prevention Program (DPP) trial demonstrated that a resource- intensive, one-on-one program combining diet and physical activity changes, could reduce the 3-year risk of type 2 diabetes by 58% compared with usual care. Consequently, the DPP is considered one of the best examples of how a nutritional program can prevent disease, and the Centers for Disease Control and Prevention (CDC) and others recommend the DPP as a first-line treatment for adults with prediabetes. The CDC’s National Diabetes Prevention Program (NDPP) is an adaptation of the DPP trial curriculum, using group-based delivery. It teaches participants to follow a low-fat, calorie-restricted diet, as this was the prevailing dietary advice when the DPP trial was designed over 30 years ago. The NDPP is now available at >1,500 sites throughout the United States and reimbursed by Medicare and other payors. Yet, despite widespread availability, only 36% of participants achieve the program goal of ≥5% body weight loss and, when measured, HbA1c reduces on average less than 0.1%. We hypothesize that adapting the NDPP to teach a different dietary strategy—a very-low-carbohydrate diet (VLCD)—will increase the effectiveness of the NDPP as a tool for type 2 diabetes risk reduction. Carbohydrate intake is the strongest factor impacting post-prandial glycemia, and a VLCD—due to its ability to reduce glycemia, weight, and the need for anti-hyperglycemic medications—is now recommended by the American Diabetes Association for treatment of type 2 diabetes. To date, there are neither high-quality, randomized controlled trials testing how effective a VLCD is at reducing the risk of type 2 diabetes among adults with prediabetes, nor randomized trials of VLCD versions of any DPP. To begin to fill this critical gap, our team has developed and pilot tested a VLCD version of the NDPP (VLC- NDPP), delivered by our CDC-recognized community partner, the National Kidney Foundation of Michigan. Our findings demonstrate that a VLC-NDPP is feasible and acceptable. We now propose to conduct a 12- month, 1:1, randomized trial that will assign 300 overweight or obese adults with prediabetes to either the standard NDPP or the VLC-NDPP. The primary outcome is glycemic control (measured by HbA1c), with secondary outcomes including body weight, body fat percentage, glycemic variability, and inflammation. We will also explore the barriers to and facilitators of glycemic control and dietary adherence using mixed methods. As the prevalence of type 2 diabetes and the understanding of personalized interventions continue to increase, there is a critical need to provide additional effective options for population-level type 2 diabetes prevention strategies. If the VLC-DPP shows promise, this trial would be a precursor to a multi-site trial with incidence of type 2 diabetes as the primary outcome.

摘要 三分之一的美国成年人患有前驱糖尿病，并且处于发展2型糖尿病的高风险之中， 健康后果。具有里程碑意义的糖尿病预防计划（DPP）试验表明，一种资源- 强化的，一对一的计划结合饮食和身体活动的变化，可以降低3年的风险， 与常规护理相比，2型糖尿病患者减少了58%。因此，民进党被认为是最好的之一， 营养计划如何预防疾病的例子，以及疾病控制中心和 美国疾病预防控制中心（CDC）和其他人推荐DPP作为成人前驱糖尿病的一线治疗。的 CDC的国家糖尿病预防计划（NDPP）是DPP试验课程的改编，使用 基于组的交付。它教导参与者遵循低脂肪，限制热量的饮食，因为这是 在30多年前设计DPP试验时，NDPP现在可以在 在美国有超过1，500个站点，并由Medicare和其他付款人报销。但尽管 广泛的可用性，只有36%的参与者实现了≥5%体重减轻的计划目标，当 经测量，HbA 1c平均降低小于0.1%。我们假设，适应NDPP教一个 不同的饮食策略--极低碳水化合物饮食（VLCD）--将提高NDPP的有效性 作为降低2型糖尿病风险的工具。碳水化合物摄入量是影响餐后血糖的最重要因素 由于其能够降低血糖、体重和抗高血糖的需要， 目前，美国糖尿病协会推荐将其用于治疗2型糖尿病。到 迄今为止，既没有高质量的随机对照试验来测试VLCD在减少 糖尿病前期成人中2型糖尿病的风险，也没有任何DPP的VLCD版本的随机试验。到 开始，以填补这一关键的差距，我们的团队已经开发和试点测试的VLCD版本的NDPP（VLC- NDPP），由我们CDC认可的社区合作伙伴密歇根州国家肾脏基金会提供。 我们的研究结果表明，VLC-NDPP是可行的和可接受的。我们现在建议进行一次12- 一项为期一个月的1：1随机试验，将300名超重或肥胖的糖尿病前期成年人分配到 标准NDPP或VLC-NDPP。主要结局是血糖控制（通过HbA 1c测量）， 次要结果包括体重、体脂百分比、血糖变异性和炎症。我们 还将探讨使用混合方法控制血糖和饮食依从性的障碍和促进因素。 随着2型糖尿病的患病率和对个性化干预措施的了解不断增加， 迫切需要为人群水平的2型糖尿病预防提供额外的有效选择 战略布局如果VLC-DPP显示出前景，该试验将是多中心试验的先驱， 2型糖尿病作为主要结局。