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Clinical Trial Summary

This study is a randomized-control pilot study that aims to evaluate Time Limited Eating (TLE) in the pediatric T1D population, implemented within the first six months after diagnosis. This period is characterized by residual β-cell function, during which TLE may have the ability to preserve and improve β-cell activity, indicated by increased C-peptide production. The investigators aim to assess the feasibility, acceptability, and safety of TLE in the pediatric T1D population, as well as to investigate the impact of TLE on β-cell function, insulin sensitivity, and glycemic control.

Clinical Trial Description

This will be a two-armed study with an intervention and control group. Feasibility and acceptability will be assessed by using questionnaires. Safety will be indicated by hypoglycemia occurrence. β-cell function and insulin sensitivity will be evaluated using mixed meal tolerance test with C-peptide and glucose levels. Glycemic control will be indicated by continuous glucose monitor (CGM). Block randomization will be utilized to ensure the groups are balanced in terms of ethnicity and BMI. The study period will be 13 weeks in duration, including a week-long run-in period and a 12 week intervention period. There will be two in-person study visits at week 0 and week 13. Anthropometrics including weight, height, and pubertal status will be evaluated at these times. Group 1- Standard Care (control) - includes a minimum 12-hour feeding window - no caloric restriction will be used - will wear a continuous glucose monitor Group 2 - TLE (intervention) - includes an 8-hour feed/16-hour fast for 7 days per week - will be instructed to consume all of their calories from 11 AM to 7 PM - can consume non-caloric beverages (water, tea, coffee) during the fasting period - will wear a continuous glucose monitor - no caloric restriction will be used ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05031429
Study type Interventional
Source Children's Hospital Los Angeles
Contact Casey Berman, MD
Phone 323-361-8848
Email [email protected]
Status Not yet recruiting
Phase N/A
Start date September 1, 2021
Completion date July 1, 2023

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