Actively Recruiting
Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
Led by Children's Hospital Los Angeles · Updated on 2025-06-24
100
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the impact of a diet plan called Time Limited Eating (TLE) on blood sugar control, B-cell function, body fat, and body mass index (BMI) in adolescents with type 2 diabetes. The study focuses on predominantly Latinx adolescents aged 12 to 21 years with type 2 diabetes and hemoglobin A1c below 9%. Researchers want to understand how limiting eating times affects health markers compared to a longer daily eating window. Participants will be randomly assigned to one of two meal timing groups for 12 weeks: a control group with a 12-hour or longer eating window without restrictions, and a TLE group with an 8-hour eating period followed by 16 hours of fasting daily. All participants receive standard nutrition counseling and physical activity and sleep recommendations according to pediatric guidelines. They will wear a continuous glucose monitor (CGM) throughout the study, changing sensors approximately every 10 to 14 days. Weekly phone calls will support adherence, address challenges, monitor safety, and review CGM data. Participants and their families will complete surveys and record daily eating windows using an app. Study staff will monitor adherence and provide behavioral support through coaching techniques. Researchers will measure changes in blood sugar levels, insulin response, body fat, and BMI at baseline, 4 weeks, and 12 weeks. The study includes ongoing safety checks and monitoring for any adverse effects. Total participation lasts about 12 weeks, with regular contact to encourage success and collect data for future studies.
CONDITIONS
Brief Title
Time Limited Eating in Adolescents With Type 2 Diabetes (KT2D)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 12 and 21 years
- Tanner stage III or above
- Diagnosis of type 2 diabetes based on ADA guidelines
- Hemoglobin A1c less than 9%
- Willing and able to follow study visits, assessments, and eating/fasting schedules
You will not qualify if you...
- Previous diagnosis of Prader-Willi Syndrome, brain tumor, or hypothalamic obesity
- Serious developmental or intellectual disability
- Past diagnosis or symptoms of eating disorders (anorexia nervosa, bulimia nervosa, binge-eating disorder)
- Physical or mental inability to participate (e.g., inability to wear CGM or undergo imaging without sedation)
- Previous or planned bariatric surgery
- Planned use of anti-obesity or certain diabetes medications
- Current participation in other interventional weight loss studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person or virtual)
Duration - 12 weeks
Participants follow an assigned meal-timing schedule (either an 8-hour eating window with 16 hours fasting or a 12-hour or more eating window) for 12 weeks while receiving standard nutritional counseling and wearing a continuous glucose monitor. Weekly phone calls are conducted to support adherence, monitor safety, and address challenges.
1 baseline visit (in-person) and weekly phone calls for 12 weeks
Trial Site Locations
Total: 1 location
1
Children's Hospital of Los Angeles
Los Angeles, California, United States, 90027
Actively Recruiting
Research Team
A
Alaina Vidmar, MD
G
Gisell Figueroa
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here