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: 10602503
• 负责人: Laura Saslow
• 金额: $ 58.37万
• 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/10602503
• 关键词: 2 arm randomized control trial; 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; Educational process of instructing; 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; Recommendation; Research; Research Personnel; Resources; Review Committee; Risk; Risk Factors; Risk Reduction; Site; Stroke; Testing; United States; Weight; Work; acceptability and feasibility; adult obesity; 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，并且患 2 型糖尿病及其毁灭性的风险很高 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 结合饮食和身体活动改变的强化、一对一计划，可以降低 3 年患病风险 与常规护理相比，2 型糖尿病减少 58%。因此，民进党被认为是最好的政党之一 营养计划如何预防疾病的示例，以及疾病控制中心和 预防 (CDC) 和其他机构建议将 DPP 作为成人糖尿病前期的一线治疗方法。这 CDC 的国家糖尿病预防计划 (NDPP) 是 DPP 试验课程的改编版，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 30 多年前设计 DPP 试验时流行的饮食建议。 NDPP 现已发布于 美国各地超过 1,500 个站点，由 Medicare 和其他付款人报销。然而，尽管 广泛普及后，只有 36% 的参与者实现了 ≥5% 体重减轻的计划目标，并且当 测量结果显示，HbA1c 平均降低不到 0.1%。我们假设调整 NDPP 来教授 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最重要的因素 血糖和 VLCD——因为它能够降低血糖、体重和抗高血糖的需要 药物治疗——现已被美国糖尿病协会推荐用于治疗 2 型糖尿病。到 迄今为止，还没有高质量的随机对照试验来测试 VLCD 在减少 糖尿病前期成人患 2 型糖尿病的风险，也没有任何 DPP 的 VLCD 版本的随机试验。到 为了开始填补这一关键空白，我们的团队开发并试点测试了 NDPP 的 VLCD 版本（VLC- NDPP），由我们的 CDC 认可的社区合作伙伴密歇根国家肾脏基金会提供。 我们的研究结果表明 VLC-NDPP 是可行且可接受的。我们现在建议进行12- 一个月的 1:1 随机试验将 300 名患有糖尿病前期的超重或肥胖成年人分配到 标准 NDPP 或 VLC-NDPP。主要结局是血糖控制（通过 HbA1c 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 还将使用混合方法探索血糖控制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， 迫切需要为人群预防 2 型糖尿病提供额外有效的选择 策略。如果 VLC-DPP 显示出希望，该试验将成为多中心试验的前兆，该试验的发生率 2 型糖尿病作为主要结局。