Clinical trial NCT05031429: Time Limited Eating in Type 1 Diabetes
Official title: Time Limited Eating in New-Onset Type 1 Diabetes: Feasibility, Acceptability, and Effect on β-cell Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes
Keywords: Type 1 Diabetes
Time Limited Eating
β-cell
Lead sponsor: Children's Hospital Los Angeles
Sponsor class: OTHER
First posted: 2021-09-01
Enrollment: 12
Sex: ALL
Minimum age (years): 12
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Acceptability and feasibility of intervention, as indicated by the "Intervention Satisfaction Survey"
timeFrame: At end of study (at 9 weeks)
measure: Change in β-cell function at 9 weeks, as indicated by mixed meal tolerance test with C-peptide levels
timeFrame: Baseline and 9 weeks
measure: Change in glycemic control at 9 weeks, as indicated by continuous glucose monitoring (percent time in range), and HbA1c
timeFrame: Up to 9 weeks; HbA1c: Baseline and 9 weeks
measure: Safety, as indicated by hypoglycemia
timeFrame: Up to 9 weeks
Secondary outcomes:
measure: Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)
timeFrame: Baseline, 9 weeks
measure: Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module
timeFrame: Baseline and 9 weeks
measure: Stress level, as indicated by Perceived Stress Scale
timeFrame: Baseline and 9 weeks
measure: Binge Eating, as indicated by Binge Eating Disorder Screener
timeFrame: Baseline and 9 weeks
measure: Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form
timeFrame: Baseline and 9 weeks
measure: Impact on activities of daily living, as indicated by Munich Chronotype Questionnaire (MCTQ)
timeFrame: Baseline and 9 weeks
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles
state: California
Study officials:
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