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

Part of paid clinical trials in Los Angeles, California.

Sponsor
Children's Hospital Los Angeles
Study ID
NCT04536480
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 21 Years
Healthy Volunteers
Not accepted

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.
  • 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 — 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.
  • 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.

Study Details

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.

Key Dates

Start date
Apr 15, 2023
Status verified
Jun 2025
Primary completion
Dec 1, 2026
Completion
Dec 1, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Control: 12 hour eating period
    Control: Habitual daily eating period (no meal time restrictions)
  • Experimental: Time Limited Eating
    Time Limited Eating: 8-hour eating period (16 hours of daily fasting).

Primary Outcome Measure

Change in percent time in range [ Time Frame: Measured at week 0,4, 12 ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Hospital of Los AngelesLos AngelesCalifornia90027
Alaina P Vidmar, MD
[email protected]
323-361-3385

Find similar trials in Los Angeles, CA

By condition
Type 2 diabetes
By specialty
EndocrinologyMetabolic healthWeight loss
By research site
Children's Hospital of Los Angeles· Los Angeles, CA

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