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.

抽象的 三分之一的美国成年人患有糖尿病前期，患有2型糖尿病及其破坏性的高风险 健康后果。具有里程碑意义的糖尿病预防计划（DPP）试验表明，资源 结合饮食和体育锻炼变化的密集，一对一的计划可以降低3年的风险 与通常的护理相比，2型糖尿病可降低58％。因此，DPP被认为是最好的之一 营养计划如何预防疾病以及疾病控制中心和 预防（CDC）和其他人建议DPP作为糖尿病前期成年人的一线治疗。 CDC的国家糖尿病预防计划（NDPP）是对DPP试验课程的改编 基于小组的交付。它教会参与者遵循低脂，卡路里限制饮食，因为这是 当DPP试验是30年前设计时，饮食建议就会占上风。 NDPP现在可以在 在美国各地> 1,500个站点，并由Medicare和其他付款人偿还。但是，目的地 宽度可用性，只有36％的参与者实现了≥5％体重减轻的计划目标，当 测得的HBA1C平均降低小于0.1％。我们假设这可以适应NDPP教 不同的饮食策略（一种非常低的碳水化合物饮食（VLCD））将提高NDPP的有效性 作为2型糖尿病风险降低的工具。碳水化合物的摄入量是影响后原理的重要因素 血糖和VLCD - 降低血糖，体重和对抗血糖的需求的能力 药物 - 现在由美国糖尿病协会推荐用于2型糖尿病的治疗。到 日期，要么有高质量的随机对照试验测试VLCD降低的有效性 患有糖尿病前期的成年人中2型糖尿病的风险，也不是任何DPP的VLCD版本的随机试验。到 开始填补这一关键空白，我们的团队已经开发并试点测试了NDPP的VLCD版本（VLC-- NDPP），由我们的CDC认可的社区合作伙伴，密歇根州国家肾脏基金会提供。 我们的发现表明，VLC-NDPP是可行的，可以接受的。我们现在建议进行12- 月，1：1，随机试验将把300个超重或肥胖的成年人分配给前期糖尿病的成年人 标准NDPP或VLC-NDPP。主要结果是血糖控制（通过HBA1C测量）， 次要结果，包括体重，体内脂肪百分比，血糖变异性和炎症。我们 还将探索使用混合方法的血糖控制和饮食依从性的障碍和促进者。 随着2型糖尿病的患病率以及对个性化干预措施的理解继续增加， 至关重要的需要为预防2型糖尿病的种群级别提供其他有效的选择 策略。如果VLC-DPP表现出承诺，则该试验将是多站点试验的先驱 2型糖尿病作为主要结果。