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)

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.12345

Why 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?

AV

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

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Time Limited EatingExperimental Treatment3 Interventions
Group II: Control: 12 hour eating periodExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Hospital Los Angeles

Lead Sponsor

Trials
257
Recruited
5,075,000+

Published Research Related to This Trial

A 4-week, 9-hour time-restricted eating (TRE) protocol significantly improved glycaemic control in 19 adults with type 2 diabetes, reducing mean 24-hour glucose concentrations and total area under the curve (AUC) without changing dietary intake or physical activity levels.
Participants experienced 10% more time in the target glucose range and 10% less time above the target range during the TRE period, indicating enhanced blood sugar management.
Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes.Parr, EB., Steventon-Lorenzen, N., Johnston, R., et al.[2023]
The three-meal diet (3Mdiet) resulted in significant weight loss (-5.4 kg) and improved glycemic control (decreased HbA1c by -1.2%) in 28 participants with type 2 diabetes over 12 weeks, compared to a six-meal diet (6Mdiet).
Participants on the 3Mdiet experienced a 26-unit reduction in daily insulin doses and showed improved clock gene expression, suggesting that this dietary approach may enhance glucose metabolism and reduce the need for insulin.
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.Jakubowicz, D., Landau, Z., Tsameret, S., et al.[2022]
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]

Citations

Effect of intermittent fasting 16:8 and 14:10 compared with ...Either IF 16:8 or 14:10 had a benefit in the percentage weight change, glucose and lipid profiles in obese diabetic patients compared with the control group.
Effect of Time-Restricted Eating on Weight Loss in Adults ...In a 6-month randomized clinical trial involving 75 adults with T2D, TRE was more effective for weight loss (−3.6%) than CR (−1.8%) compared with controls.
Effects of time-restricted eating on glycemic control in type ...Notably, another study conducted in patients with type 2 diabetes revealed more substantial weight loss (−4.52 kg, −4.28 %) following 6 months of 8-h TRE ...
Intermittent Fasting: What is it, and how does it work?Intermittent fasting involves switching between fasting and eating on a regular schedule. This type of fasting could manage your weight or even some forms ...
Time Restricted Eating As Treatment (TREAT) for Diabetes ...Time-restricted Feeding (TRF), typically have daily fasting intervals of 12-21 hours per day. There were no mean changes in tension, depression, anger, vigor, ...
Is Time-Restricted Eating Safe in the Treatment of Type 2 ...Time-restricted eating (TRE) has been shown to improve body weight and glucose metabolism in people at high risk of type 2 diabetes.
Ten-hour time-restricted eating reduces weight, blood ...In animal models, time-restricted feeding (TRF) can prevent and reverse aspects of metabolic diseases. Time-restricted eating (TRE) in human pilot studies ...
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