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

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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.