Meal Timing for Type 2 Diabetes
(TimeLEAD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores how meal timing might help manage type 2 diabetes in adolescents. Researchers aim to determine if eating within an 8-hour window each day, known as Time Limited Eating (TLE), can improve blood sugar control, body fat, and overall health. Participants will either follow this 8-hour eating plan or continue eating without time restrictions. Adolescents diagnosed with type 2 diabetes who regularly see an endocrinologist and can adhere to the study's plan might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management for adolescents.
Will I have to stop taking my current medications?
The trial requires that participants do not have any planned use of anti-obesity or other diabetes medications. If you are currently taking such medications, you may need to stop them to participate.
What prior data suggests that Time Limited Eating is safe for adolescents with type 2 diabetes?
Research has shown that time-restricted eating (TRE) is generally safe for people with type 2 diabetes. In several studies, participants followed an 8-hour eating window, similar to the one under current investigation. These studies found that TRE can aid weight loss and improve sugar metabolism.
In one study involving 75 adults with type 2 diabetes, those practicing TRE lost more weight than those who did not. Another study found that participants lost about 4.5 kg (nearly 10 pounds) in six months using this method. These results suggest that TRE is effective for weight management and well-tolerated by participants.
No serious safety issues have been reported in these studies. While further testing continues, TRE has shown promise as a safe option for people, especially those at high risk for diabetes-related problems.12345Why are researchers excited about this trial?
Researchers are excited about the meal timing approach for Type 2 Diabetes because it offers a unique way to manage blood sugar levels without medication. Unlike standard treatments like metformin or insulin that focus on altering blood sugar directly, time-limited eating restructures when you eat, specifically allowing an 8-hour eating window while fasting for 16 hours daily. This method could simplify diabetes management by aligning eating patterns with the body's natural rhythms, potentially improving glucose control and reducing the need for medication. Researchers hope to find out if this approach can be an effective, lifestyle-based intervention for better managing Type 2 Diabetes.
What evidence suggests that Time Limited Eating might be an effective treatment for type 2 diabetes?
This trial will compare Time Limited Eating (TLE) with a control group that follows a habitual daily eating period without meal time restrictions. Studies have shown that TLE, where people eat during an 8-hour period and fast for the remaining 16 hours, can help manage blood sugar and weight in people with type 2 diabetes. In one study, participants who followed TLE lost about 4.5 kg (around 10 pounds) over six months. Another study found that TLE resulted in a 3.6% weight loss, outperforming other diet methods. TLE has also been linked to improved blood sugar and fat levels. These findings suggest that TLE could be a promising way to manage type 2 diabetes.23467
Who Is on the Research Team?
Alaina P Vidmar, MD
Principal Investigator
Children's Hospital Los Angeles
Are You a Good Fit for This Trial?
Adolescents aged 12-21 with Type 2 Diabetes (T2D) and a Hemoglobin A1c below 9% can join this trial. They must be at least in Tanner stage III of puberty, able to follow the study's schedule, and not have any eating disorders or conditions like Prader-Willi Syndrome.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants and families complete baseline surveys and receive training on CGM use
Treatment
Participants follow either a Time Limited Eating schedule or a Control eating schedule for 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Continuous Glucose Monitor
- Control
- Time Limited Eating
Find a Clinic Near You
Who Is Running the Clinical Trial?
Children's Hospital Los Angeles
Lead Sponsor