Time Limited Eating in Type 1 Diabetes (TLET1D)

August 14, 2023 updated by: jennifer raymond, Children's Hospital Los Angeles

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90027
        • Children's Hospital Los Angeles

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 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
Experimental: 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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"
Time Frame: At end of study (at 9 weeks)
Likert scale "Agree strongly" is 1, "Agree" is 2, "Neutral" is 3, "Disagree" is 4, and "Disagree strongly" is 5. Lower scores indicate more satisfaction, higher scores indicate low satisfaction.
At end of study (at 9 weeks)
Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels
Time Frame: Baseline and 9 weeks
C-peptide and glucose levels will be performed at baseline and 60-, 90-, and 120-minutes post-meal. Baseline plasma C-peptide concentration divided by the baseline plasma glucose concentration will be calculated as a pragmatic marker of β-cell function. The area under the stimulated C-peptide curve will then be calculated, which will be the primary outcome examined.
Baseline and 9 weeks
Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c
Time Frame: Up to 9 weeks; HbA1c: Baseline and 9 weeks
Continuous glucose monitors will be worn for duration of the study, glycemic control will be evaluated using percent time in range. HbA1c will reflect glycemic control over time.
Up to 9 weeks; HbA1c: Baseline and 9 weeks
Safety, as indicated by hypoglycemia
Time Frame: Up to 9 weeks
Hypoglycemia will be defined as blood sugar < 70 mg/dL on continuous glucose monitor. Frequency and severity of hypoglycemia will be used to assess safety of intervention.
Up to 9 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
Time Frame: Baseline, 9 weeks
24-hour dietary recall, ~30 minutes to complete.
Baseline, 9 weeks
Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module
Time Frame: Baseline and 9 weeks
Likert scale "Never" is 0, "Almost Never" is 1, "Sometimes" is 2, "Often" is 3, and "Almost Always" is 4
Baseline and 9 weeks
Stress level, as indicated by Perceived Stress Scale
Time Frame: Baseline and 9 weeks
Likert scale "Never" is 0, "Almost Never" is 1, "Sometimes" is 2, "Fairly Often" is 3, and "Very Often" is 4
Baseline and 9 weeks
Binge Eating, as indicated by Binge Eating Disorder Screener
Time Frame: Baseline and 9 weeks
Likert scale "Never or rarely" is 0, "Sometimes" is 1, "Often" is 2, "Always" is 3. Additionally, two yes or no questions.
Baseline and 9 weeks
Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form
Time Frame: Baseline and 9 weeks
Likert scale "Never" is 1, "Rarely" is 2, "Sometimes" is 3, "Often" is 4, "Always" is 5
Baseline and 9 weeks
Impact on activities of daily living, as indicated by Munich Chronotype Questionnaire (MCTQ)
Time Frame: Baseline and 9 weeks
Assessment of sleep schedule, school schedule, time spent outdoors. Multiple choice and open-ended questions.
Baseline and 9 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Los Angeles

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2022

Primary Completion (Actual)

June 13, 2023

Study Completion (Actual)

June 30, 2023

Study Registration Dates

First Submitted

August 1, 2021

First Submitted That Met QC Criteria

August 26, 2021

First Posted (Actual)

September 1, 2021

Study Record Updates

Last Update Posted (Actual)

August 16, 2023

Last Update Submitted That Met QC Criteria

August 14, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHLA-21-00269

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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