Treating Type 2 Diabetes by Reducing Postprandial Glucose Elevations: A Paradigm Shift in Lifestyle Modification

通过降低餐后血糖升高治疗 2 型糖尿病：生活方式改变的范式转变

• 批准号: 9235547
• 负责人: Daniel Joseph Cox
• 金额: $ 69.53万
• 依托单位: UNIVERSITY OF VIRGINIA
• 依托单位国家: 美国
• 财政年份: 2016
• 资助国家: 美国
• 起止时间: 2016-09-20 至 2020-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9235547
• 关键词: Address; Adult; Adverse effects; Aerobic Exercise; American; Behavior; Behavior Therapy; Behavioral; Blood Glucose; Body Weight; Body Weight decreased; Caloric Restriction; Carbohydrates; Clinical; Diabetes Mellitus; Disease Progression; Educational process of instructing; Effectiveness; Epidemic; Exercise; Feedback; Food; Future; Glucose; Glycosylated hemoglobin A; Health; High Density Lipoproteins; Individual; Informal Social Control; Instruction; Insulin Resistance; Intervention; Lead; Life Style; Literature; Low-Density Lipoproteins; Maintenance; Manuals; Measurement; Measures; Medical; Mental Depression; Metabolic; Metabolic Control; Metformin; Modeling; Non-Insulin-Dependent Diabetes Mellitus; Outcome; Participant; Patients; Pharmaceutical Preparations; Physical activity; Physiological; Pilot Projects; Play; Program Effectiveness; Randomized; Recommendation; Research; Review Literature; Role; Sampling; Self Perception; Structure; Testing; Time; United States National Institutes of Health; Weight; Work; base; behavior change; compare effectiveness; cost; depressive symptoms; empowered; empowerment; follow-up; glucose monitor; improved; insulin sensitivity; post intervention; prevent; primary outcome; programs; psychologic; secondary outcome; self reliance; success; therapy design

BACKGROUND: Type 2 diabetes (T2D) is a growing epidemic in the U.S. with devastating complications that result in major health and personal costs. To address this, the American Diabetes Association recommends a lifestyle program that focuses on weight loss through caloric restriction and exercise as an initial or an adjunct treatment to pharmacological interventions. However, its general applicability is limited because some individuals with T2D do not need to lose weight, do not want to lose weight, cannot lose weight, or cannot maintain weight loss over a lifetime. Recent research indicates that a major contributor to poor metabolic control is postprandial glucose (PPG) elevation. We have developed a treatment option that focuses on reducing PPG without requiring weight loss. This lifestyle program is comprehensive, integrated, and efficient. Over 5 sessions, this program empowers individuals to use Glycemic load of food, Exercise, and Monitoring glucose (GEM) in a systematic manner. GEM's 1.03% HbA1c reduction compared favorably to both conventional weight loss (0.64% reduction with 42 sessions of Look AHEAD) and continual use of a first line medication (0.9% reduction with Metformin). When enhancing the quantity and quality of glucose feedback with Continuous Glucose Monitoring (CGM), GEM reduced HbA1c by 1.30%. AIMS: This project will determine how GEM compares to conventional weight reduction at short- and long- term follow-up in a large, representative sample of adults with type 2 diabetes. At the same time, we will test a conceptual model based on a review of the literature postulating that the effects of GEM are modulated by the quality and quantity of glucose feedback. This has important implications for long-term maintenance; since the model proposes a cascade in which increasing either the quantity or quality of glucose feedback improves immediate behavior change through positive and negative glucose consequences. These contingencies may lead to improved PPG and insulin sensitivity, and in turn, improved metabolic control. This cascade may produce ancillary benefits that could help maintain long-term success, e.g. greater empowerment and fewer depressive symptoms. APPROACH: 200 participants with poorly controlled T2D will be randomized to 1 of 4 groups that manipulate both the focus on postprandial glucose and the quality and quantity of glucose feedback. Short- and long-term benefits will be assessed using medical, behavioral and psychological measures obtained at baseline, 3 months post-intervention and 12 months post-intervention. IMPACT: If GEM is shown to be effective and enduring, it will provide an alternative to the conventional weight-loss focused lifestyle modification. GEM has the potential to improve metabolic control, increase self- reliance, and slow disease progression. Because GEM is manual-based, it will be easy to deploy and will give it the potential to impact a large proportion of the adults with T2D.

背景：2型糖尿病(T2D)在美国是一种日益流行的疾病，具有破坏性的并发症 导致了重大的健康和个人成本。为了解决这个问题，美国糖尿病协会建议 生活方式计划，重点是通过限制卡路里和锻炼来减肥，作为最初的或辅助的 药物干预的治疗。然而，它的普遍适用性是有限的，因为一些 患有T2D的人不需要减肥，不想减肥，不能减肥，或者不能 在一生中保持减肥。最近的研究表明，新陈代谢不良的主要原因之一 对照组为餐后血糖(PPG)升高。我们已经开发了一种治疗方案，重点是 在不需要减肥的情况下降低PPG。这个生活方式项目是全面的、综合的、高效的。 在5个疗程中，该计划使个人能够使用血糖负荷的食物、锻炼和监测 系统地使用葡萄糖(GEM)。创业板1.03%的HbA1c降幅对两者都有利 常规减肥(减少0.64%，42个疗程的展望)和继续使用第一线 药物治疗(二甲双胍减少0.9%)。在增强葡萄糖反馈的数量和质量时 连续血糖监测(CGM)，GEM使HbA1c降低1.30%。 目标：该项目将确定GEM与传统减重在短期和长期- 对具有代表性的成人2型糖尿病患者的大样本进行长期随访。同时，我们将测试一个 基于文献回顾的概念模型，该模型假设创业板的效应受 葡萄糖反馈的质量和数量。这对长期维护具有重要影响；因为 模型提出了一个级联模型，其中增加葡萄糖反馈的数量或质量都会改善 通过积极和消极的血糖后果，立即改变行为。这些或有事件可能 从而改善PPG和胰岛素敏感性，进而改善代谢控制。这一级联可能 产生可帮助保持长期成功的辅助效益，例如更大的赋权和更少的 抑郁症状。 方法：将200名T2D控制不佳的参与者随机分成4组中的一组 既注重餐后血糖，又注重血糖质量和数量的反馈。短期和长期 将使用在基线上获得的医疗、行为和心理测量来评估惠益，3 干预后3个月和干预后12个月。 影响：如果创业板被证明是有效和持久的，它将提供一种替代传统的 关注减肥的生活方式调整。创业板具有改善代谢控制、提高自我调节能力的潜力 依赖，减缓疾病的发展。因为GEM是基于手动的，所以它将很容易部署，并将提供 它有可能影响很大比例的成人T2D。