Time Limited Eating in Type 1 Diabetes

NCT ID: NCT05031429

Last Updated: 2023-08-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-06-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control - Standard Care

• 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 Type: NO_INTERVENTION

No interventions assigned to this group

Intervention - Time Limited Eating

• 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

Group Type: EXPERIMENTAL

Time Limited Eating

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Los Angeles

OTHER

Sponsor Role: lead

Responsible Party

jennifer raymond

Chief of the Division of Endocrinology, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Children's Hospital Los Angeles

Los Angeles, California, United States

Countries

United States

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Other Identifiers

CHLA-21-00269

Identifier Type: -

Identifier Source: org_study_id