ODP004 Glucose Profiles and Insulin Sensitivity in Adults with Overweight/Obesity Participating in a Weight Loss Intervention based on Early Time-Restricted Eating plus Daily Caloric Restriction vs Daily Caloric Restriction Alone

BACKGROUND: Emerging literature suggests that short-term (<1 week) time restricted eating (TRE) may improve glucose tolerance and insulin sensitivity, but few studies have evaluated the longer-term effects of TRE on glycemic outcomes. The aim of this study was to compare 24-hour glucose profiles and insulin sensitivity in participants enrolled in a 12-week behavioral weight loss intervention based on early TRE plus daily caloric restriction (E-TRE+DCR) or DCR alone. METHODS: Eighty-one adults with overweight or obesity (age 18-50 years, BMI 27-45 kg/m 2) were randomized to E-TRE (10-hour eating window starting within 3 hours of waking) plus DCR (35% daily caloric restriction) or DCR alone for 12 weeks. Each participant wore a continuous glucose monitor (CGM, Freestyle Libre Pro) for 7 days at baseline and week 12. Fasting glucose and insulin levels were drawn for assessment of insulin sensitivity by homeostasis model assessment-estimated insulin resistance (HOMA-IR) at baseline and week 12. Analysis of Covariance (ANCOVA) was used to assess whether there were differences in glucose measures by randomized group. Between-group differences in minutes spent over glucose of 120 mg/dL and excursions over glucose of 120 mg/dL were assessed using either negative binomial or Poisson regression. All models were adjusted for the change in weight from baseline to week 12. RESULTS: Of the 81 adults randomized, 45 participants had valid CGM data and 40 had valid glucose, insulin and HOMA-IR data at baseline and 12 weeks (missing data due to COVID-19 related restrictions on in person research). There were no significant differences in sex, age, BMI or percent with prediabetes between groups (88% female, age 39.2 +/- 6.9 years, BMI 33.8 +/- 5.7 kg/m 2, 17% with prediabetes). After adjusting for weight loss, there were no between-group differences in overall average sensor glucose, minutes spent above 120 mg/dL, number of glucose excursions above 120 mg/dL, daytime or nighttime average sensor glucose, mean amplitude of glycemic excursions, or standard deviation or coefficient of variation of glucose levels. There was a significant difference in week 12 day-night sensor ratio between the two groups, with those in the E-TRE+DCR group having day-night sensor ratio mean 0.27 (95% confidence interval -0.53, -0. 00) units lower on average than those in the DCR group at week 12, adjusting for baseline. There were no between-group differences in fasting glucose, insulin, or HOMA-IR. CONCLUSIONS: While the E-TRE+DCR group had a slightly lower day-to-night sensor ratio compared to the DCR group, this difference is likely not clinically meaningful because there were no observed differences in day or night average sensor glucose. Because participants with diabetes were excluded and only 17% of participants had prediabetes, our ability to detect changes in glucose profiles and insulin sensitivity may have been limited. Presentation: No date and time listed