Effects of Low-calorie Sweetened Beverage Restriction in Youth with Type 1 Diabetes

限制低热量甜味饮料对患有 1 型糖尿病的青少年的影响

• 批准号: 9979429
• 负责人: Allison Sylvetsky
• 金额: $ 22.69万
• 依托单位: GEORGE WASHINGTON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-04-01 至 2022-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9979429
• 关键词: 12 year old; Address; Adherence; Adolescent; Adult; Age; Aspartame; Beverages; Biological Assay; Biological Markers; Blinded; Blood; Blood Glucose; Calories; Cardiovascular Diseases; Child; Childhood; Collaborations; Complications of Diabetes Mellitus; Consumption; Counseling; Crystallization; Development; Diabetes Mellitus; Disease; Dose; Education; Enrollment; Fatty acid glycerol esters; Follow-Up Studies; Food; Fruit; Genes; Glucose; Glucose Intolerance; Glucose Transporter; Glycosylated hemoglobin A; Goals; HDL-triglyceride; Hawaiian population; Health; Healthy Eating; High Prevalence; Human; Hyperglycemia; Impairment; Incidence; Inflammation; Inflammatory; Instruction; Insulin-Dependent Diabetes Mellitus; Intake; Intervention; Intervention Studies; Intervention Trial; Light; Link; Lipids; Low Prevalence; Low-Density Lipoproteins; Magnetic Resonance Imaging; Measurement; Measures; Medical center; Metabolic; Metabolic syndrome; Monitor; Mus; Obesity; Observational Study; Outcome; Parents; Participant; Patient Self-Report; Patients; Physiological; Plasma; Potassium; Prevention; Randomized; Randomized Controlled Trials; Records; Reporting; Risk; Risk Factors; Rodent; Role; Stroke; Sweetening Agents; TNF gene; Time; Triglycerides; Urine; Visceral; Vulnerable Populations; Water; Youth; absorption; arm; cardiometabolic risk; cardiometabolism; cardiovascular disorder risk; clinically relevant; cohort; diabetes management; dosage; gatorade; glucose monitor; glycemic control; group intervention; gut microbiota; improved; insulin sensitivity; patient population; programs; recruit; stem cells; sugar; sweetened beverage; trial comparing; urinary

Abstract This project aims to determine whether replacement of beverages containing low-calorie sweeteners (hereafter LCSB) with unsweetened still or seltzer water improves glycemic variability (time in target range) and reduces visceral adiposity and systemic inflammation in children with type 1 diabetes (T1D). While LCSB are widely consumed in youth with T1D, their role in cardiometabolic health is controversial. LCS consumption is reported to promote glucose intolerance in rodents and humans, and incubation of human mesenchymcal stem cells with sucralose at clinically relevant doses upregulated expression of glucose transporter genes as well as markers of fat accumulation and inflammation. This is alarming because inflammation and hyperglycemia drive early cardiovascular disease (CVD) in youth with T1D and positive associations between LCS consumption, CVD, and stroke are consistently reported in observational analyses in adults without diabetes. These findings are particularly concerning for patients with T1D, who already struggle with glycemic control and are at heightened cardiometabolic risk. To address these outcomes, we plan to conduct a two-arm randomized controlled trial comparing effects of replacement of usual sucralose or aspartame + acesulfame-potassium containing LCSB consumption (the majority of LCSB consumed by children contain either sucralose or aspartame + ace-K) with unsweetened still or seltzer water for 12 weeks (referred to as LCSB restriction) on glycemic variability, visceral adiposity, and systematic inflammation in 60 children ages 6-12 years old with T1D. We will also examine the feasibility and acceptability of the proposed intervention and monitor adherence using both self-report and objective (urinary sucralose and acesulfame-potassium) measures. Blinded continuous glucose monitoring (CGM), MRI, and blood assays will be performed at baseline, after which participants will be randomized to either LCSB restriction or continuation of usual LCSB intake (control). Participants in both groups will be instructed to complete photo-assisted, online, three day food records, with the help of their parents, during weeks 1, 6, and 12. All participants and their parent will receive instructions on how to complete photo-assisted food records, education on continuous glucose monitoring (CGM), and counseling on general healthy eating strategies. Those in the intervention group will receive additional guidance on how to avoid LCSB. CGM, blood assays and MRI will be performed again at study follow up. If LCSB restriction improves glycemic variability and lowers visceral adiposity and systemic inflammation, these findings will inform the development of a larger and longer-term trial to elucidate mechanisms underlying LCS effects and will justify or challenge the standard practice of encouraging LCSB among children with T1D.

抽象的 该项目旨在确定是否可以替代含有低热量甜味剂（以下简称 LCSB）与不加糖的静止水或苏打水一起改善血糖变异性（目标范围内的时间）并减少 1 型糖尿病 (T1D) 儿童的内脏肥胖和全身炎症。虽然 LCSB 被广泛 患有 T1D 的青少年食用它们，其在心脏代谢健康中的作用存在争议。报告濒海战斗舰消耗量 促进啮齿动物和人类的葡萄糖不耐受，以及人类间充质干细胞的孵化 临床相关剂量的三氯蔗糖可上调葡萄糖转运蛋白基因的表达以及 脂肪堆积和炎症的标志物。这是令人担忧的，因为炎症和高血糖会导致 患有 T1D 的青少年的早期心血管疾病 (CVD) 与 LCS 消耗之间存在正相关， 在没有糖尿病的成年人中，观察分析一致报道了心血管疾病和中风。这些发现 对于 1 型糖尿病 (T1D) 患者来说尤其令人担忧，他们已经在血糖控制方面遇到困难，并且正处于 心脏代谢风险增加。为了解决这些结果，我们计划进行两组随机 对照试验比较替代普通三氯蔗糖或阿斯巴甜+安赛蜜的效果 含有 LCSB 消费（儿童消费的大部分 LCSB 含有三氯蔗糖或 阿斯巴甜 + ace-K）与不加糖的蒸馏水或苏打水一起服用 12 周（称为 LCSB 限制） 60 名 6-12 岁儿童的血糖变异性、内脏肥胖和系统性炎症 T1D。我们还将审查拟议干预措施的可行性和可接受性，并监测遵守情况 使用自我报告和客观（尿三氯蔗糖和安赛蜜）测量。致盲 将在基线时进行连续血糖监测 (CGM)、MRI 和血液检测，之后 参与者将被随机分配接受 LCSB 限制或继续常规 LCSB 摄入（对照）。 两组参与者将被指示完成照片辅助的在线三天食物记录， 在第 1、6 和 12 周期间，他们会得到父母的帮助。所有参与者及其父母都会收到有关 如何完成照片辅助食物记录、连续血糖监测 (CGM) 教育以及 一般健康饮食策略的咨询。干预组的人将获得额外的 有关如何避免 LCSB 的指导。研究随访时将再次进行 CGM、血液检测和 MRI 检测。如果 LCSB 限制可改善血糖变异性并降低内脏肥胖和全身炎症，这些 研究结果将为开展更大规模、更长期的试验提供信息，以阐明 LCS 的潜在机制 影响，并将证明或挑战鼓励 T1D 儿童 LCSB 的标准做法。