Impact of Meal Timing on Glycemic Profiles in Adolescents with Type 2 Diabetes

进餐时间对 2 型糖尿病青少年血糖曲线的影响

• 批准号: 10571631
• 负责人: Alaina P Vidmar
• 金额: $ 16.96万
• 依托单位: CHILDREN'S HOSPITAL OF LOS ANGELES
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-01-01 至 2026-11-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10571631
• 关键词: Adherence; Adolescent; Adult; Age; Behavior; Behavioral; Beta Cell; Bioinformatics; Black race; Body Composition; Body Weight; Body Weight decreased; Body fat; Caloric Restriction; Cell physiology; Cells; Characteristics; Child Nutrition; Childhood; Clinical; Clinical Trials Design; Communities; Complex; Continuous Glucose Monitor; Country; Data; Deterioration; Development; Diabetes Mellitus; Diagnosis; Diet; Dietary Intervention; Dietary intake; Disease Progression; Dual-Energy X-Ray Absorptiometry; Eating; Energy Metabolism; Environment; Fasting; Fatty acid glycerol esters; Functional disorder; Funding; Glycogen; Glycosylated hemoglobin A; Goals; Hepatic; Hepatocyte; Hour; Individual; Institution; Intervention; Latino; Life Style; Lipids; Liver; Macronutrients Nutrition; Magnetic Resonance Imaging; Measurement; Measures; Medical; Mentored Patient-Oriented Research Career Development Award; Mentors; Metabolic; Metformin; Methods; Monitor; Movement; Multicenter Trials; Non-Insulin-Dependent Diabetes Mellitus; Nutritional; Obesity; Participant; Peripheral; Personal Satisfaction; Physical activity; Physicians; Pilot Projects; Population; Prediabetes syndrome; Prevalence; Psychologist; Randomized; Recommendation; Regimen; Research; Safety; Scanning; Schedule; Scientist; Severities; Sleep; Specific qualifier value; Statistical Methods; Structure; Technology; Testing; Time; Training; Visceral fat; Youth; aged; blood glucose regulation; cardiometabolism; career development; circadian pacemaker; comparison control; cost; daily functioning; dietary; dietary approach; disease phenotype; dosage; effectiveness evaluation; flexibility; functional restoration; gender expression; glucose metabolism; glucose monitor; glucose production; glycemic control; improved; indexing; insight; insulin secretion; insulin sensitivity; interest; intervention effect; lifestyle intervention; lipid metabolism; mathematical ability; minimal risk; oxidation; post intervention; recruit; reduced food intake; response; secondary outcome; skills

CANDIDATE: Alaina Vidmar is a pediatric clinical scientist specializing in treatment of adolescents with obesity and type 2 diabetes (T2D). The proposed study will focus on investigating if time-limited eating (TLE: 8-hour eating/16-hour fasting) in adolescents with T2D reduces glycemic excursions, delays β-cell dysfunction, and reduces body fat mass compared to prolonged eating period (12+hours). This K23 Award will provide her with advanced training in clinical trial design and advanced statistical methods, pediatric nutrition and body composition measurement, and glucose monitoring technology, all of which are required for her to compete for independent R01 funding. RESEARCH CONTEXT: Preliminary evidence, mostly in adults, has shown that TLE reduces body weight and fat mass, improves insulin sensitivity, reduces hepatic fat accumulation, and is safe with minimal risk when compared to prolonged eating windows and has no negative effect on daily function or lifestyle behaviors. 1–12 Because of its simplicity, TLE may represent a more feasible approach for adolescents than other caloric restriction regimens. Our preliminary data support TLE feasibility, acceptability, and safety in adolescents with obesity, with and without diabetes.13–15 However, no trial to date has studied the effects of TLE on glycemic control and body composition in adolescents with T2D. We hypothesize that TLE will reduce glycemic excursions, improve β-cell function, and reduce body fat mass in adolescents with T2D when compared to prolonged eating periods. One-hundred adolescents with T2D (aged 14-21 years), with a hemoglobin A1c (HbA1c) < 9%, and on Metformin monotherapy, will be recruited. All participants will be randomized to one of two meal-timing schedules to be followed for 12 weeks: (1) Control: >12-hour eating or (2) TLE. We will examine the effects of TLE versus control in 3 specific aims: (1) Effects on glucose control as measured by percent time in range (captured from continuous glucose monitoring data), Hemoglobin A1c, and β-cell function (mean change in insulinogenic index after a mixed meal tolerance test); (2) Effects on body composition and liver fat (DEXA and magnetic resonance imaging); and (3) Effects on sleep, physical activity, and dietary intake. CAREER DEVELOPMENT: Dr. Vidmar has access to a rich academic research environment, one of the largest pediatric T2D populations in the country, the support of her institution, and a stellar mentoring committee consisting of (1) Dr. Goran, a pediatric nutritional scientist, (2) Dr. Raymond, a physician-scientist with expertise in diabetes technology, (3) Dr. Ramon Durazo-Arvizu, a statistician, (4) Dr. Espinoza, an expert in clinical bioinformatics, and (5) Dr. Salvy, a behavioral and clinical psychologist with expertise in TLE implementation. The two co- primary mentors, Drs. Goran and Raymond will be responsible for guiding Dr. Vidmar in achieving the milestones towards transition to independence. In summary, this proposal meets a critical need for finding an effective dietary intervention for treatment of adolescents with T2D and provides Dr. Vidmar with a robust training platform, and structured mentoring path towards an R01-level competitive application.

候选人：Alaina Vidmar是 和2型糖尿病（T2D）。 饮食/16小时禁食）在具有T2D的青少年中，可以减少血糖偏移，延迟β细胞功能障碍，并减少 将体内脂肪量减少到长时间的饮食期（12小时以上）。 临床试验设计和高级统计方法，小儿营养和身体的高级培训 组成测量和葡萄糖监测技术，她都需要所有的竞争 独立的R01资金。 减轻体重和脂肪质量，提高胰岛素敏感性，降低肝脂肪的积累，并且是安全的 长期延长到木窗窗户的风险很小，对每日功能或没有负面影响 生活方式的行为。 比其他热量限制方案。 肥胖症的青少年，有或没有糖尿病。13-15然而，迄今为止尚无试验研究TLEE的影响 关于T2D的青少年的血糖控制和身体成分。 比较时，血糖游览，改善β细胞功能并减少T2D青少年的体内脂肪量 长时间的饮食期。 （HBA1C）<9％，二甲双胍单一疗法将被招募。 遵循两个餐食的时间表：（1）控制：> 12小时的进食或（2）我们将检查 TLE与控制在3个特定目的中的影响：（1）对葡萄糖控制的影响，如时间百分比衡量 在范围内（通过连续葡萄糖监测数据捕获），血红蛋白A1C和β细胞功能（平均变化） 在混合餐测试之后的胰岛素发育指数中； 和磁共振成像）和（3）对睡眠，体育锻炼和饮食摄入的影响 发展：Vidmar Hass博士进入丰富的学术研究环境，这是最大的小儿之一 该国的T2D Poptions，她的机构的支持以及由（1）组成的出色指导委员会 小儿营养科学家Goran博士（2）Raymond博士，糖尿病专业知识的医生 - 科学家 技术，（3）统计学家Ramon Durazo-Arvizu博士，（4）Espinoza博士，临床生物信息学的经验， （5）Salvy博士，具有实施经验的行为和临床心理学家。 主要导师，Goran和Raymond将负责指导Vidmar博士实现里程碑 摘要中要过渡到独立性。 用T2D治疗青少年的饮食间隔，并为Vidmar博士提供了强大的培训平台， 以及通往R01级竞争应用程序的结构化指导路径。