100 Participants Needed

Meal Timing for Type 2 Diabetes

(TimeLEAD Trial)

AV
YP
GF
Overseen ByGisell Figueroa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

Time-restricted eating (TRE) appears to be generally safe for people with type 2 diabetes, with studies showing it is feasible and achievable. Some participants reported mild side effects like fatigue, constipation, and headaches, but these were transient.12345

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

AV

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

Participant must be willing and able to adhere to the assessments, visit schedules, and eating/fasting periods
Your blood sugar level (Hemoglobin A1c) is less than 9%.
I have been diagnosed with Type 2 Diabetes.
See 2 more

Exclusion Criteria

I have had an eating disorder or symptoms of one.
I have been diagnosed with Prader-Willi Syndrome, a brain tumor, or hypothalamic obesity.
You are currently taking part in another program to lose weight.
See 4 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks
1 visit (in-person or virtual)

Baseline Assessment

Participants and families complete baseline surveys and receive training on CGM use

1 week
1 visit (in-person)

Treatment

Participants follow either a Time Limited Eating schedule or a Control eating schedule for 12 weeks

12 weeks
Weekly phone encounters

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks
2 visits (in-person or virtual)

Treatment Details

Interventions

  • Continuous Glucose Monitor
  • Control
  • Time Limited Eating
Trial Overview The trial is testing Time Limited Eating (TLE), where participants eat within an 8-hour window and fast for 16 hours daily, against a control group with a regular eating period over 12 hours. The goal is to see if TLE improves blood sugar control and body composition in adolescents with T2D.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Time Limited EatingExperimental Treatment3 Interventions
Time Limited Eating: 8-hour eating period (16 hours of daily fasting).
Group II: Control: 12 hour eating periodExperimental Treatment3 Interventions
Control: Habitual daily eating period (no meal time restrictions)

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

Findings from Research

A time-restricted eating (TRE) intervention designed for people with type 2 diabetes and overweight includes a two-phase approach: an initial strict phase followed by a more flexible phase tailored to individual needs.
Support from healthcare professionals, family, and peers is crucial for maintaining motivation and adherence to the TRE regimen, emphasizing a whole-person approach that considers participants' past experiences.
Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes.Hempler, NF., Bjerre, N., Varming, AR., et al.[2023]
In a 12-week study involving 120 overweight adults with type 2 diabetes, time-restricted feeding (10-hour eating window) significantly improved glycaemic control, as evidenced by a 1.54% reduction in HbA1c and a weight loss of nearly 3 kg compared to a control group.
Participants in the time-restricted feeding group also showed improved insulin sensitivity and reduced levels of triglycerides and cholesterol, suggesting additional cardiovascular benefits alongside better diabetes management.
Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial.Che, T., Yan, C., Tian, D., et al.[2021]
A 4-week time-restricted eating (TRE) intervention was found to be feasible for individuals with type 2 diabetes, with participants adhering to the eating window about 72% of the time, which helped reduce daily energy intake.
Despite the feasibility of TRE, it did not significantly improve glycaemic control or body mass in participants, indicating that while it may help with dietary management, it may not lead to substantial health improvements in blood sugar levels.
Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study.Parr, EB., Devlin, BL., Lim, KHC., et al.[2022]

References

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]
Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. [2021]
Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. [2022]
Intermittent fasting plus early time-restricted eating versus calorie restriction and standard care in adults at risk of type 2 diabetes: a randomized controlled trial. [2023]
Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]
Reduction in Glycated Hemoglobin and Daily Insulin Dose Alongside Circadian Clock Upregulation in Patients With Type 2 Diabetes Consuming a Three-Meal Diet: A Randomized Clinical Trial. [2022]
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