Meal Timing for Type 2 Diabetes
(TimeLEAD Trial)
Trial Summary
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 data supports the effectiveness of the treatment Continuous Glucose Monitor, CGM, Continuous Glucose Sensor, Glucose Monitoring System, Control, Placebo, Standard Care, Time Limited Eating, Time-Restricted Eating, TRE, Intermittent Fasting, 16:8 Eating Pattern, Leangains Diet for Type 2 Diabetes?
Research shows that time-restricted eating (TRE), a form of intermittent fasting, can improve blood sugar control in people with type 2 diabetes by limiting eating to a specific time window each day. Studies found that TRE can help manage daily blood sugar levels and improve glucose tolerance, especially when combined with early meal timing.12345
Is time-restricted eating safe for people with type 2 diabetes?
How does time-restricted eating differ from other treatments for type 2 diabetes?
Time-restricted eating (TRE) is unique because it focuses on limiting the hours during which food is consumed each day, rather than restricting calories or specific foods. This approach can improve blood sugar control and weight management by aligning eating patterns with the body's natural circadian rhythms, which is different from traditional methods like continuous calorie restriction or medication.12456
What is the purpose of 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.
Research Team
Alaina P Vidmar, MD
Principal Investigator
Children's Hospital Los Angeles
Eligibility Criteria
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
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
Treatment Details
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