Time Restricted Eating for Type 2 Diabetes

(EaT2DM Trial)

Overseen By Jeanne M Walker, DNP, ANP-BC

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rockefeller University

Must not be taking: Anti-obesity, Steroids, Insulin, GLP-1

Disqualifiers: Cirrhosis, Autoimmune, Pregnant, Smoker, others

Compensation: Varies

Number of Visits: 2

Duration: 15 days

10 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Time-restricted feeding limits caloric intake to active daytime hours with fasting for 14 to 16 hours. It has shown great promise as a novel intervention for stabilizing blood glucose, reducing weight, and improving cardiovascular disease outcomes. However, this approach has not been tested on people with diabetes, a group that would benefit from improved blood glucose and weight loss. The impact of Time-Restricted Eating on Type 2 Diabetes Study (EaT2D Study) is a randomized six-day weight stable crossover feeding study in the Day Patient/Outpatient unit of The Rockefeller Hospital investigating how the time of day that meals are eaten affects weight, blood sugar and blood pressure. The investigators will compare an early time-restricted eating intervention (80% of calories consumed before 2 pm) to a usual feeding pattern (50% of calories consumed after 4 pm) among 10 persons with type 2 diabetes to determine effects on blood sugar and small molecules found in the blood. Studies have shown benefits of eating during active periods (mornings and early afternoon) for metabolic health (blood sugar, body weight) compared to eating during inactive periods (evening and bedtime). Eating earlier in the day may lead to reduced sugar stores, burning fat for energy, and decreased inflammation when compared to eating later in the day. The investigators will compare the effects of eating earlier during the day for six days versus later in the day for six days, on blood sugar, blood pressure, blood ketones, and other measures of metabolic health in diabetic participants. Studies in animals supports these benefits.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications, including anti-obesity medications, insulin, sulfonylureas, and GLP-1 receptor agonists, to participate.

Is time-restricted eating safe for people with type 2 diabetes?

Existing studies suggest that time-restricted eating is generally safe for people with type 2 diabetes, as long as their medication is monitored and adjusted. However, more research is needed to make specific recommendations. ^{1 2 3 4 5}

How does time-restricted eating differ from other treatments for type 2 diabetes?

Time-restricted eating is unique because it focuses on limiting the hours during which food is consumed each day, rather than changing the types of food eaten. This approach aims to improve blood sugar control and weight management by aligning eating patterns with the body's natural circadian rhythms, which is different from traditional diabetes treatments that often involve medication or specific dietary changes. ^{1 2 3 5 6}

What data supports the effectiveness of the treatment Time Restricted Eating for Type 2 Diabetes?

Research suggests that time-restricted eating can improve blood sugar control and insulin sensitivity in people with type 2 diabetes. It may also help reduce daily calorie intake, which can be beneficial for managing diabetes. ^{1 2 3 5 6}

Who Is on the Research Team?

Jose Aleman, MD, PhD

Principal Investigator

The Rockefeller University Hospital

Are You a Good Fit for This Trial?

This trial is for individuals with type 2 diabetes interested in how meal timing affects their condition. Participants should be willing to follow a specific eating schedule, either consuming most calories before 2 pm or sticking to their usual feeding pattern with more calories after 4 pm.

Inclusion Criteria

Fluent in the English language

Willing to eat only the food provided

Willing to follow the feeding schedule, including fasting for 16 hours/day for six days

Exclusion Criteria

Smoked tobacco within the last 3 months

I have an autoimmune disease like rheumatoid arthritis or lupus.

Currently pregnant

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Treatment

Participants undergo a randomized crossover feeding study with early time-restricted eating and usual feeding pattern interventions

15 days

Daily visits (outpatient)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Time Restricted Eating

Trial Overview The study tests time-restricted eating by comparing two groups: one eats the majority of daily calories early (before 2 pm), and the other follows a typical diet with more calories consumed later (after 4 pm). The focus is on changes in weight, blood sugar, and blood pressure over six days.

How Is the Trial Designed?

Group I: Time restricted eating Active Control 2 Interventions

Selection of the order of the arms is randomized prior to active study participation. Caloric requirements and meal selection are done during screening and calculated to maintain weight neutrality. In Arm 1, participants are required to start breakfast at 8 AM, complete lunch by 2 PM (80% of total daily calories) and snack by 4 PM (20% of calories). They then fast from 4 PM till 8 AM the next day (16 hour fast). This is done for six days. The next day is for testing (2 hour oral glucose tolerance test, resting energy expenditure, research and clinical blood tests) prior to crossover to Arm 2.

Group II: Usual feeding pattern, with meals eaten ad lib Placebo Group 1 Intervention

Participants consume the same meals as in the other arm, but may eat ad lib without prolonged fasting. This is done for six days. Post-testing including 2 hour oral glucose tolerance test, resting energy expenditure, and research and clinical blood tests are done the following day.

Who Is Running the Clinical Trial?

Rockefeller University

Lead Sponsor

Trials

162

Recruited

16,700+

NYU Langone Health

Collaborator

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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 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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

In a 6-month randomized clinical trial with 75 participants who had type 2 diabetes, time-restricted eating (TRE) led to a significant weight loss of 3.56% compared to controls, while daily calorie restriction (CR) did not show a significant difference in weight loss.

Both TRE and CR resulted in similar reductions in hemoglobin A1c (HbA1c) levels, indicating that TRE can be an effective dietary strategy for improving glycemic control without the need for calorie counting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. Pavlou, V., Cienfuegos, S., Lin, S., et al.[2023]

Time-restricted eating (TRE) appears to be safe for individuals with type 2 diabetes, based on four completed studies and 14 ongoing studies, provided that their antidiabetic medications are monitored and adjusted accordingly.

Despite the promising safety profile of TRE, the limited number of studies and their low generalizability highlight the need for further research to establish clear recommendations for its efficacy and safety in managing type 2 diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is Time-Restricted Eating Safe in the Treatment of Type 2 Diabetes?-A Review of Intervention Studies. Uldal, S., Clemmensen, KKB., Persson, F., et al.[2022]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Time-restricted feeding improves blood glucose and insulin sensitivity in overweight patients with type 2 diabetes: a randomised controlled trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Designing a Co-created Intervention to Promote Motivation and Maintenance of Time-Restricted Eating in Individuals With Overweight and Type 2 Diabetes. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Time-Restricted Eating as a Nutrition Strategy for Individuals with Type 2 Diabetes: A Feasibility Study. [2022]

4. Ireland pubmed.ncbi.nlm.nih.gov

Time-restricted eating improves measures of daily glycaemic control in people with type 2 diabetes. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Effect of Time-Restricted Eating on Weight Loss in Adults With Type 2 Diabetes: A Randomized Clinical Trial. [2023]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Is Time-Restricted Eating Safe in the Treatment of Type 2 Diabetes?-A Review of Intervention Studies. [2022]