Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)

NCT04536480 | Recruiting DMC FDA Device

• 2 other identifiers: CHLA-22-003971K23DK134801-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

To find the effectiveness of a diet plan (Time Limited Eating or TLE) on glycemic control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes.

Conditions

Pediatric Obesity; Type 2 Diabetes; Time Restricted Eating

Keywords

Intermitted-fasting; Type 2 Diabetes; Time Limited Eating

Outcome Measures

Primary Outcomes (4)

• Change in percent time in range

  Change in percent time in range, as measured on CGM over the study period

  Measured at week 0,4, 12

• Change in Hemoglobin A1c

  Change in hemoglobin A1c at week 12 compared to baseline

  Week 12 compared to baseline

• Change in insulinogenic index

  Change in insulinogenic index after mixed meal tolerance test

  Week 12 compared to baseline

• Change in total body fat mass (kg)

  Change in total body fat mass as measured by DEXA at week 12 compared to baseline

  Week 12 compared to baseline

Secondary Outcomes (5)

• ASA 24 Dietary Recall

  Measured at week 0,4, 12

• International Physical Activity Questionnaire (IPAQ)

  Measured at week 0,4, 12

• Munich Chronotype Questionnaire for children and adolescents (MTCQ)

  Measured at week 0,4, 12

• Pittsburg Sleep Quality Index

  Measured at week 0,4, 12

• Change in BMI in excess of the 95th percentile (%BMIp95)

  Measured at week 0,4, 12

Other Outcomes (2)

• Binge eating disorder screen

  Measured at week 0,4, 12

• Adult eating behavior Questionnaire

  Measured at week 0,4, 12

Study Arms (2)

Control: 12 hour eating period

EXPERIMENTAL

Control: Habitual daily eating period (no meal time restrictions)

Behavioral: Components Common to All Study Arms.; Behavioral: Control; Device: Continuous Glucose Monitor

Time Limited Eating

EXPERIMENTAL

Time Limited Eating: 8-hour eating period (16 hours of daily fasting).

Behavioral: Time Limited Eating; Behavioral: Components Common to All Study Arms.; Device: Continuous Glucose Monitor

Interventions

Time Limited Eating BEHAVIORAL

The TLE intervention arm will involve instructing participants to consume their usual kind and amount of food and beverages (all calories) within a pre-specified 8-hour period, fasting for the remaining 16-hours. They will be free to divide their food and beverage intake into as many meals or snacks as desired during the 8-hour period. Participants will be allowed to consume non-caloric beverages (water, tea, coffee) during the fasting period. No energy restriction will be required.

Also known as: TLE

Time Limited Eating

Components Common to All Study Arms. BEHAVIORAL

All participants will receive two hours of standard nutrition counseling recommended for adolescents living with T2D. No specific caloric restriction will be recommended. All participants will maintain their usual lifestyle, including physical activity and sleep patterns. Physical activity and sleep recommendations consistent with the American Academy of Pediatrics guidelines for adolescents will be encouraged but not formally prescribed.

Control: 12 hour eating period; Time Limited Eating

Control BEHAVIORAL

Participants assigned to the control arm will be instructed to consume food over a 12-h or more eating window. No energy restriction will be required.

Control: 12 hour eating period

Continuous Glucose Monitor DEVICE

All participants will be trained to wear a blinded continuous glucose monitor sensor using manufacturer educational materials under the supervision of research staff. Participants will be asked to wear the CGM for the duration of the study. During each study visit, the CGM reader will be connected to the site database to create an individual participant report. Participants will be provided enough sensors to replace the sensor every 14 days. The participants and guardians will be educated on how to use the CGM and receive 1:1 coaching on how to change the sensor, which will be completed either independently or under study team guidance. At each weekly phone meeting, study staff will monitor any challenges related to CGM wear, including participant discomfort, skin adherence, and other issues.

Control: 12 hour eating period; Time Limited Eating

Eligibility Criteria

• Age: 12 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Children's Hospital Los Angeles: lead

Study Sites (1)

Children's Hospital of Los Angeles

Los Angeles, California, 90027, United States

RECRUITING

MeSH Terms

Conditions

Pediatric Obesity; Diabetes Mellitus, Type 2; Intermittent Fasting

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Alaina Vidmar, MD

  Children's Hospital Los Angeles

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alaina Vidmar, MD

CONTACT

323-361-3385; avidmar@chla.usc.edu

Gisell Figueroa

CONTACT

323-361-4664; gfigueroa@chla.usc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Pediatric, Pediatric Endocrinologist

Study Record Dates

• First Submitted: August 27, 2020
• First Posted: September 2, 2020
• Study Start: April 15, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 24, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)