Time restricted EAting for Type 2 diabetes and MEtabolic health: The TEA TIME trial study protocol

Recent findings have suggested that implementing the emerging weight-loss strategy of time-restricted eating (TRE) for 6 weeks can have beneficial effects on the key pathophysiologic determinants of type 2 diabetes (T2DM) - namely, pancreatic beta-cell function and insulin resistance. Given the chronic nature of T2DM and the general challenge of long-term adherence to dietary interventions, a critical question is the durability of such effects. Specifically, we seek to determine whether TRE can improve the metabolic health of patients with T2DM over 1 year.

In this open-label, parallel-arm, randomized controlled trial, individuals with overweight/obesity and T2DM of <10 years duration will be randomized to either standard lifestyle recommendations or TRE. The TRE protocol will consist of 18 hours of fasting and a 6 hour window of eating (between 2-8 PM) each day. The duration of the intervention will be 52-weeks and participants will undergo metabolic characterization at baseline, 12-24-, 36- and 52-weeks. The primary outcome of pancreatic beta-cell function will be assessed by Insulin Secretion-Sensitivity Index-2 (ISSI-2). Additional metabolic measures will include insulin resistance and glucose homeostasis.

TRE may represent an adjunct therapeutic approach for improving the metabolic profile of overweight/obese individuals with T2DM while also providing the capacity for modification of its underlying pathophysiology. This evaluation of the durability of the metabolic effects of TRE on beta-cell function and insulin resistance could thus identify a role for this dietary strategy as a disease-modifying intervention early in the course of T2DM.

clinicaltrials.gov NCT07272460.