Time Limited Eating in Type 1 Diabetes

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Other: Time Limited Eating


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control - Standard Care<br>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<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability and feasibility of intervention, as indicated by the Intervention Satisfaction Survey | 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 | 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 | 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 | 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) | 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 | 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 | 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 | 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 | 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) | Assessment of sleep schedule, school schedule, time spent outdoors. Multiple choice and open-ended questions. | Baseline and 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Time Limited Eating, β-cell