NCT05031429

Time Limited Eating in Type 1 Diabetes

Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Children's Hospital Los Angeles · Academic / Other
• Sex: All
• Age: 12 Years – 25 Years
• Healthy volunteers: Not accepted

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.

Detailed 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 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

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
OTHER	Time Limited Eating	Includes an 8-hour feed/16-hour fast for 7 days per week, with consumption of all of calories in the afternoon/evening. Can consume non-caloric beverages (water, tea, coffee) during the fasting period. No caloric restriction will be used.

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-06-13
• Completion: 2023-06-30
• First posted: 2021-09-01
• Last updated: 2023-08-16

Locations

1 site across 1 country: United States