The Impact of Time Restricted Eating on Type 2 Diabetes Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Age 18-75 able to give consent

• BMI \>25 kg/m2

• Hemoglobin A1C ≥ 6.5%

• Willing to eat only the food provided

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

• Usual sleep time is between 10 PM and 8 AM

• Fluent in the English language

Locations
United States
New York
The Rockefeller University Hospital
RECRUITING
New York
Contact Information
Primary
Jose Aleman, MD, PhD
jaleman@rockefeller.edu
617-312-9368
Backup
Jeanne M Walker, DNP, ANP-BC
walkerj@rockefeller.edu
516-457-6407
Time Frame
Start Date: 2025-05-29
Estimated Completion Date: 2028-03-30
Participants
Target number of participants: 10
Treatments
Active_comparator: Time restricted eating
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.
Placebo_comparator: Usual feeding pattern, with meals eaten ad lib
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.
Related Therapeutic Areas
Sponsors
Collaborators: NYU Langone Health
Leads: Rockefeller University

This content was sourced from clinicaltrials.gov