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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.
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)
Group 2 - TLE (intervention)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control - Standard Care | No Intervention |
| |
| Intervention - Time Limited Eating | Experimental |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital Los Angeles | Los Angeles | California | 90027 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32320147 | Background | Gabel K, Varady KA. Feasibility of Time-Restricted Eating. Obesity (Silver Spring). 2020 May;28(5):860. doi: 10.1002/oby.22785. No abstract available. | |
| 30216730 | Background | Gabel K, Hoddy KK, Varady KA. Safety of 8-h time restricted feeding in adults with obesity. Appl Physiol Nutr Metab. 2019 Jan;44(1):107-109. doi: 10.1139/apnm-2018-0389. Epub 2018 Sep 14. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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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 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |