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

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

Interventions

BEHAVIORAL

Time Limited Eating

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.

BEHAVIORAL

Components Common to All Study Arms.

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.

BEHAVIORAL

Control

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.

DEVICE

Continuous Glucose Monitor

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.

Sponsors & Collaborators

• Children's Hospital Los Angeles

  lead OTHER

Principal Investigators

• Alaina Vidmar, MD · Children's Hospital Los Angeles

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Max Age

21 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-04-15

Primary Completion

2026-12-01

Completion

2027-12-01

FDA Device

Yes

Countries

• United States

Study Locations