Time Limited Eating in Type 1 Diabetes

NCT05031429 | Completed

• 1 other identifier: CHLA-21-00269
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetes; Time Limited Eating; β-cell

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• Dietary patterns, as indicated by the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24)

  Baseline, 9 weeks

• Quality of life, as indicated by Pediatric Quality of Life Inventory (PedsQL), Diabetes Module

  Baseline and 9 weeks

• Stress level, as indicated by Perceived Stress Scale

  Baseline and 9 weeks

• Binge Eating, as indicated by Binge Eating Disorder Screener

  Baseline and 9 weeks

• Anxiety, as indicated by Neuro-QOL-Anxiety-Short Form

  Baseline and 9 weeks

Study Arms (2)

Control - Standard Care

NO INTERVENTION

* includes a minimum 12-hour feeding window for 7 days per week * no caloric restriction will be used * will wear a continuous glucose monitor

Intervention - Time Limited Eating

EXPERIMENTAL

* 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

Interventions

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.

Intervention - Time Limited Eating

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• negative pancreatic antibodies
• unwillingness to wear a CGM

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Related Publications (36)

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MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief of the Division of Endocrinology, Principal Investigator

Study Record Dates

• First Submitted: August 1, 2021
• First Posted: September 1, 2021
• Study Start: January 1, 2022
• Primary Completion: June 13, 2023
• Study Completion: June 30, 2023
• Last Updated: August 16, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)