Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-21
SponsorChildren's Hospital Los Angeles
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Design model
Parallel
Treatments tested in this trial
Time Limited Eating
BehavioralThe 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.
BehavioralAll 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
BehavioralParticipants 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
DeviceAll 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.
Treatment groups
100 Participants
are divided into 2 treatment groupsGroup A: Control: 12 hour eating periodExperimental treatment 3 interventions
Group B: Time Limited EatingExperimental treatment 3 interventions
Trial outcomes
Primary outcomes
1
Change in percent time in range
Change in percent time in range, as measured on CGM over the study period
Time frame
Measured at week 0,4, 122
Change in Hemoglobin A1c
Change in hemoglobin A1c at week 12 compared to baseline
Time frame
Week 12 compared to baseline3
Change in insulinogenic index
Change in insulinogenic index after mixed meal tolerance test
Time frame
Week 12 compared to baseline4
Change in total body fat mass (kg)
Change in total body fat mass as measured by DEXA at week 12 compared to baseline
Time frame
Week 12 compared to baselineSecondary outcomes
1
ASA 24 Dietary Recall
Twenty-four-hour dietary recalls will be conducted for all participants pre- and post-intervention. One weekday and one weekend day will be collected for all participants.
Time frame
Measured at week 0,4, 122
International Physical Activity Questionnaire (IPAQ)
The International Physical Activity Questionnaire (IPAQ) has been developed to estimate levels of habitual physical activity across different countries and socio-cultural environments and will be collected at 5 time points.
Time frame
Measured at week 0,4, 123
Munich Chronotype Questionnaire for children and adolescents (MTCQ)
The Munich ChronoType Questionnaire (MCTQ) is a self-rated scale to assess sleep structure, patterns, duration, and quality and will be collected at 5 time points.
Time frame
Measured at week 0,4, 124
Pittsburg Sleep Quality Index
PSI self-reported sleep scale of quality and quantity
Time frame
Measured at week 0,4, 12Other outcomes
1
Binge eating disorder screen
The 7 item Binge-Eating Disorder Screener is a brief screener for BED, can assist physicians in identifying patients who may have BED and making the necessary follow-up decisions related to patient referrals or additional assessment and potential diagnosis of BED.
Time frame
Measured at week 0,4, 122
Adult eating behavior Questionnaire
The AEBQ will be used to assess participants' approach to food and eating along three dimensions: emotional, external, and restrained eating. There is a high degree of stability for each of these three eating behavior scales. The DEBQ has high internal consistency and validity. We will compare changes in DEBQ scores across study arms to monitor possible iatrogenic effects of TLE.
Time frame
Measured at week 0,4, 12Sponsors and contacts
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Source ClinicalTrials.gov