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Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function
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.
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 BMI. The study period will be 9 weeks in duration, including a week-long run-in period and an 8-week intervention period. There will be two in-person study visits at week 0 and week 9. 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 for 7 days per week * 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 in the afternoon/evening period * can consume non-caloric beverages (water, tea, coffee) during the fasting period * will wear a continuous glucose monitor * no caloric restriction will be used
Age
12 - 25 years
Sex
ALL
Healthy Volunteers
No
Children's Hospital Los Angeles
Los Angeles, California, United States
Start Date
January 1, 2022
Primary Completion Date
June 13, 2023
Completion Date
June 30, 2023
Last Updated
August 16, 2023
12
ACTUAL participants
Time Limited Eating
OTHER
Lead Sponsor
Children's Hospital Los Angeles
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT07455994