Time Limited Eating in Type 1 Diabetes (TLET1D)

Children's Hospital Los Angeles

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Other: Time Limited Eating

Study type: Interventional

Funder types: Other

Identifiers

NCT05031429

CHLA-21-00269

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: All

Ages: 12 to 25 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• includes age of 12-25 years
• T1D diagnosed within 6 months
• at least one positive pancreatic antibody including glutamic acid decarboxylase (GAD) antibody, islet tyrosine phosphatase 2 (IA2) antibody, or insulin antibody
• can be on either insulin injections or insulin pump
• can be of any BMI status
• can speak any language

Exclusion criteria

• negative pancreatic antibodies
• unwillingness to wear a CGM

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

Control - Standard Care

No Intervention group

Description:

* includes a minimum 12-hour feeding window for 7 days per week * no caloric restriction will be used * will wear a continuous glucose monitor

Intervention - Time Limited Eating

Experimental group

Description:

* 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

Treatment:

Other: Time Limited Eating