Time Restricted Eating for Type 2 Diabetes
(EaT2DM Trial)

Recruiting in Palo Alto (17 mi)

Overseen byJose Aleman, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Rockefeller University

Trial Summary

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.

Research Team

Jose Aleman, MD, PhD

Principal Investigator

The Rockefeller University Hospital

Eligibility Criteria

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

I am between 18 and 75 years old and can give consent.

Willing to eat only the food provided

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Exclusion Criteria

Smoked tobacco within the last 3 months

I have an autoimmune disease like rheumatoid arthritis or lupus.

Currently pregnant

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Treatment Details

Interventions

Time Restricted Eating (Behavioural Intervention)

Trial OverviewThe 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.

Participant Groups

2Treatment groups

Active Control

Placebo Group

Group I: Time restricted eatingActive Control2 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 libPlacebo Group1 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.