Time Limited Eating in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

— TLET1D  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05031429
• Other study ID #: CHLA-21-00269
• Status: Completed
• Phase: N/A
• Start date: January 1, 2022
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Children's Hospital Los Angeles
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 30, 2023
• Est. primary completion date: June 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospital Los Angeles	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Los Angeles

Country where clinical trial is conducted

United States, 

References & Publications (36)

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* Note: There are 36 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	Change in ß-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 ß-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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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