Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: Impact of Meal Timing on Glycemic Profiles in Adolescents With Type 2 Diabetes
Brief Summary: Because of its simplicity, TLE may represent a more feasible approach for adolescents than other caloric restriction regimens based on macronutrient composition and kilocalories.
Our preliminary data support TLE feasibility, acceptability, and safety in adolescents with obesity, with and without T2D.
However, no trial to date has studied the effects of TLE on glycemic control and body composition in adolescents with T2D.
Our long-term goal is to determine whether TLE is a beneficial as part of the medical regimen early in diagnosis in adolescents living with T2D, and if so, to identify: 1) participant characteristics associated with positive response, 2) mechanisms by which TLE operates, and 2) the best methods to administer TLE to maximally harness its effects.
Therefore, the aim of this study will be to compare cardiometabolic effects of TLE (8-hr eating period/16-hr of daily fasting) versus a prolonged eating period (12+hour eating period) in a randomized pilot study with careful control of timely compliance, dietary composition, calorie intake, and physical activity to accurately capture the dosage of the intervention received.
We hypothesize that TLE will minimize glycemic excursions, delay ?-cell deterioration, and reduce body fat mass in adolescents with T2D when compared to prolonged eating periods.
One-hundred adolescents with T2D 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 period or (2) TLE.