Skip to main content
OpenTrials
Completed

NCT Number: NCT05031429

Time Limited Eating in Type 1 Diabetes

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

12 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Time Limited Eating

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Secondary outcomes

  1. 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.

  2. 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

  3. 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

  4. 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.

  5. 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

  6. 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.

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Registry information

Official study title

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

Acronym: TLET1D

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Sep 1, 2021
Registry last updated
Aug 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.