Time Restricted Eating As a Viable Alternative to Caloric Restriction for Treating Hyperglycemia in a Population with Type 2 (T2DM) diabetes

时间限制饮食作为热量限制的可行替代方案治疗 2 型 (T2DM) 糖尿病患者的高血糖症

• 批准号: 10580820
• 负责人: LISA S CHOW
• 金额: $ 33.25万
• 依托单位: UNIVERSITY OF MINNESOTA
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10580820
• 关键词: Accounting; Address; Age; Behavioral; Body Weight Changes; Body Weight decreased; Body mass index; Caloric Restriction; Calories; Cellular Phone; Clinical Trials; Confusion; Continuous Glucose Monitor; Coupled; Data; Data Reporting; Diabetes Mellitus; Dietitian; Disease; Eating; Educational process of instructing; Energy Intake; Feasibility Studies; Food; Glycosylated hemoglobin A; Goals; Home; Hour; Hyperglycemia; Intake; Intervention; Knowledge; Measures; Metformin; Mission; National Institute of Diabetes and Digestive and Kidney Diseases; Newly Diagnosed; Non-Insulin-Dependent Diabetes Mellitus; Outcome Assessment; Overweight; Participant; Patient Participation; Patient Self-Report; Patients; Persons; Physical activity; Play; Population; Prediabetes syndrome; Quality of life; Randomized; Randomized, Controlled Trials; Recommendation; Technology; Testing; Time; Time-restricted feeding; Translating; Visit; Weight; Weights and Measures; actigraphy; cost; dietary; glycemic control; improved; innovation; men; obese patients; preference; primary outcome; programs; transmission process; virtual visit

ABSTRACT With the support of PAS-20-160 “Small R01s for Clinical Trials Targeting Diseases within the Mission of NIDDK,” we will perform a feasibility study to test our overall hypothesis that TRE presents a viable alternative to caloric restriction for improving glycemic measures and reducing weight in overweight/obese patients [BMI:25-35 kg/m2] with metformin-only treated Type 2 diabetes (T2DM). The rationale for this study arises from the observation that intentional caloric restriction plays an integral part in glycemic management in patients with newly diagnosed/early-stage T2DM. Yet intentional caloric restriction is difficult to sustain due to multiple barriers, including challenges arising from acquiring the necessary knowledge, teaching the intervention, cost of delivery and potential burden on quality of life. In contrast to intentionally restricting calories, time restricted eating (TRE), focuses on restricting the eating window. This simplified view of eating allows participants to eat ad libitum per their dietary preferences during a daily time frame. TRE is associated with weight loss in patients without T2DM and improves glycemic measures in patients with prediabetes, however its effects on glycemic measures, especially when accounting for weight change, in patients with T2DM remains unknown. This study will involve a 24-week intervention of TRE vs Caloric Restriction (n=56 total, n=28 per group) which will be staff supervised for 12 weeks and self-maintained for 12 weeks. We will use innovative state of the art technology such as Zoom-based virtual visits, mobile phone-based food record, wifi-enabled scale for weekly weights, continuous glucose monitoring and actigraphy to implement our interventions and assess outcomes. Our Specific Aims include: Aim #1: Compare the effect of TRE vs Caloric Restriction on glycemic measures, Aim#2: Compare the effect of TRE vs Caloric Restriction on weight, Aim #3: Compare the effect of TRE vs Caloric Restriction on intervention burden. The impact and significance of this feasibility study is to provide preliminary data to support a definitive randomized controlled trial of TRE to treat hyperglycemia in patients with T2DM.

摘要