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?

This trial aims to determine if eating most meals earlier in the day can help people with type 2 diabetes better manage their blood sugar and weight. Participants will follow two different eating schedules: one where 80% of calories are consumed before 2 PM and another where more calories are consumed after 4 PM. Researchers seek to understand how meal timing (time-restricted eating) affects blood sugar, blood pressure, and overall metabolic health. The trial seeks individuals with type 2 diabetes who have a BMI over 25, an A1C of at least 6.5%, and are willing to adhere to specific meal times and fasting for six days. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research on meal timing and its impact on diabetes management.

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.

What prior data suggests that time-restricted eating is safe for people with type 2 diabetes?

Research has shown that time-restricted eating (TRE) is generally safe for people with type 2 diabetes. Studies have found that TRE can improve blood sugar levels and support weight loss. For instance, one study discovered that people with type 2 diabetes who practiced TRE lost more weight than those who did not. Another study showed that TRE was not only safe but also helped lower blood sugar levels and body weight in people using insulin.

In other studies, participants found TRE easy to follow, and most remained in the study, indicating that TRE is well-tolerated. Overall, evidence suggests that TRE is a safe way to manage diabetes, with added benefits for controlling weight and blood sugar. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for type 2 diabetes typically involve medications that help manage blood sugar levels, such as metformin or insulin. However, time-restricted eating is unique because it focuses on when you eat rather than what you eat. This method encourages eating within an 8-hour window and fasting for 16 hours, which may improve blood sugar control and insulin sensitivity without medication. Researchers are excited about this approach because it could offer a lifestyle-based alternative that supports weight neutrality and potentially reduces the reliance on drugs. Plus, it empowers individuals to manage their diabetes through dietary timing, which is a novel and promising angle.

What evidence suggests that time-restricted eating might be an effective treatment for type 2 diabetes?

Research has shown that time-restricted eating (TRE) can improve blood sugar control and reduce body weight. One study found that TRE lowered fasting blood sugar levels by an average of 0.74 mmol/L. Another study showed that people with type 2 diabetes who practiced TRE lost more weight than those who did not. TRE also helped lower blood pressure and improved how the body uses sugar. In this trial, participants will follow a time-restricted eating schedule in one arm, eating earlier in the day and fasting for longer periods, which might help manage type 2 diabetes. ^{2 6 7 8 9}

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

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]

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 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]

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 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]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S026156142500216X

Effects of time-restricted eating on glycemic control in type ... Human studies demonstrate that TRE helps to reduce body weight and fat mass, improve glucose tolerance and lower blood pressure in individuals with overweight ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40806442/

Time-Restricted Eating Improves Glycemic Control in ... Meta-analyses of six eligible studies demonstrated that TRE significantly reduced fasting glucose (mean difference [MD]: -0.74 mmol/L; 95% CI: - ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2811116

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.

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03940482

Time Restricted Eating As Treatment (TREAT) for Diabetes ... There is observational evidence from Ramadan studies of Diabetic patients that glycaemic control and lipid parameters improve over a 4-week fasting period. ...

5. diabetologia-journal.org diabetologia-journal.org/2022/07/26/study-on-time-restricted-eating-reveals-limiting-food-intake-to-daytime-shows-promising-beneficial-metabolic-effects-in-adults-with-type-2-diabetes/

Study on time restricted eating reveals limiting food intake ... Study on time restricted eating reveals limiting food intake to daytime shows promising beneficial metabolic effects in adults with type 2 diabetes.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9671354/

Time-restricted eating for patients with diabetes and ... Time-restricted eating is a safe and feasible intervention, and may offer cardiovascular and metabolic benefits for patients with diabetes and prediabetes.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1499404625000910

Time-Restricted Eating is a Feasible Dietary Strategy in the ... We demonstrated that 12 weeks of TRE was feasible in individuals with overweight/obesity and type 2 diabetes in terms of easy recruitment and high retention and ...

8. diabetesjournals.org diabetesjournals.org/care/article/46/2/463/148123/Efficacy-and-Safety-of-Intermittent-Fasting-in

Efficacy and Safety of Intermittent Fasting in People With ... Our data demonstrate that IF over 12 weeks in insulin-treated people with type 2 diabetes is safe, reduces HbA1c, body weight, and total daily ...

9. mdpi.com mdpi.com/2072-6643/14/11/2299

Is Time-Restricted Eating Safe in the Treatment of Type 2 ... Recent studies have shown that TRE can lead to weight loss and improvement of insulin sensitivity and glucose tolerance in people with overweight and high risk ...