RecruitingNot ApplicableNCT04536480

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


Sponsor

Children's Hospital Los Angeles

Enrollment

100 participants

Start Date

Apr 15, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 12 YearsMax Age: 21 Years

Interventions

BEHAVIORALTime 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.

BEHAVIORALComponents 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.

BEHAVIORALControl

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.

DEVICEContinuous 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.


Locations(1)

Children's Hospital of Los Angeles

Los Angeles, California, United States

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NCT04536480


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