An interventional study of Meal timing and Time restricted eating in Type 2 Diabetes, sponsored by Rockefeller University. Terminated at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Rockefeller University · Not applicable, Interventional, and Other
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.
Early Time Restricted Eating (eTRE) is a meal timing strategy that restricts the daily eating window to the first 6-8 waking hours of the day, while extending the fasting window between the final meal of the day and the first meal the following morning.
There is an increasing body of evidence that circadian misalignment caused by changes in sleeping and eating behaviors is a significant contributor to obesity and cardiometabolic disease, and late-night eating behaviors are associated with obesity, weight loss inhibition, and various cardiovascular disease risk factors. While the mechanisms underlying these correlations are not well understood, these effects are most likely due to suboptimal timing of caloric intake against diurnal variations in hormone and metabolite activity. Therefore, eTRE shows great promise as a novel intervention for addressing obesity and related cardiovascular outcomes. In support of this, recent studies have demonstrated weight-independent benefits of eTRE on measures of insulin sensitivity and cardiac risk. However, studies to date have primarily focused on metabolically healthy or prediabetic populations and the effect of this dietary practice on individuals with type 2 diabetes has not yet been evaluated.
To this end, the investigators propose to conduct a randomized isocaloric 15-day crossover feeding trial in the outpatient unit at The Rockefeller University Hospital (RUH) comparing an eTRE intervention (feeding window 8 AM-4 PM; 80% of calories consumed prior to 2 PM; remaining 20% to be consumed by 4 PM) to a Usual Feeding Pattern (UFP) (50% of calories consumed after 4 PM) among 10 persons with type 2 diabetes and obesity to determine effects on glycemic variation and various time-in-range metrics. The primary hypothesis of this study is that restriction of caloric intake to earlier in the day will have metabolic benefits in terms of glycemic variation and time in hyperglycemia relative to consuming the majority of calories later in the day, as in the control arm. Additionally, the investigators anticipate no increase in hypoglycemia in the eTRE arm compared to the UPF control arm. This feeding study provides a unique opportunity to study the weight-independent effects of eTRE on a population that has frequently been excluded from dietary studies in this area, yet for whom diet and lifestyle modifications are foundational components of treatment. Additionally, the proposed work will complement our recent study performed at Rockefeller University Hospital (RUH), "The Time-Restricted-Feeding Effects on Inflammation and Obesity" (TRIO) Study, which utilized a similar study design to show the weight-independent glycemic benefits of eTRE in individuals with prediabetes and obesity.
The investigators propose to obtain glucometric data including glycemic variation and various time in range metrics by Continuous Glucose Monitoring (CGM), circulating advanced glycation end-products (AGEs), and targeted plasma metabolomic profiles as surrogate measures of overall dysglycemia affected by the eTRE intervention in the RUH metabolic study.
The collaborative research proposed between RUH and New York University (NYU) Obesity Center in this application will take advantage of the expertise of both centers and advance the science of obesity and cardiovascular disease. Members of our team have extensive experience in clinical dietary studies and advanced glucometric analysis. The investigators will be able to evaluate the effectiveness of eTRE as a weight-independent therapeutic strategy for type 2 diabetes management and identify the metabolic pathways invoked, thereby synergistically expanding the work of each institution.
The rationale for this study is that early time-restricted eating (eTRE) has been shown to improve glycemic variation in a weight-neutral setting within 48 hours in individuals with prediabetes, making it a promising dietary intervention to mitigate dysglycemia. However, it has not been studied in individuals with type 2 diabetes.
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This study's enrollment of 2 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
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Exclusion Criteria:
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.
Other: Meal timing · Other: Time restricted eating
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.
Other: Usual feeding pattern.
Participants either eat all of their daily calories between 8 AM and 4 PM with 16 hours fasting for six days, or they eat the same meals ad lib daily for six days. After post-testing, they crossover to the other arm.
Eating restricted to 8 AM - 2 PM for 80% of caloric intake, the remaining 20% consumed by 4 PM, subsequent 16-hour fasting (4 PM-8 AM) each day for six days while on Time Restricted Arm.
Participant consumes usual diet ad lib without enforced fasting period for six days while on Usual Feeding Pattern arm.
Change in glycemic variation by Mean Amplitude of Glycemic Excursion (MAGE) in the Early Time Restricted Eating (eTRE) arm relative to the usual feeding pattern (UFP) arm between Day 1, Day 8, and Day 15. arm
Glycemic variation (changes in glucose levels in milligrams per deciliter (mg/dL) will be measured by continuous glucose monitoring (Abbott Freestyle Libre) recorded every 5 minutes for the entire study, as well as 2-hour oral glucose tolerance testing (measured by glucose measurements in mg/dL every 30 minutes for 120 minutes), at baseline testing and upon completion of each arm (Days 1, 8, 15).
Time frame: From Day 1-15 of study intervention.
Diurnal and prandial variation of GLP-1 will correlate with improved glycemia (serum glucose measured in mg/dL) in the eTRE arm
Measure of change in diurnal and prandial variation of GLP-1 levels during glucose tolerance test in the eTRE arm relative to the UPF arm between Days1, 8, and 15.
Time frame: Day 1 through Day 15
Diurnal and fasting variation of beta-hydroxybutyrate will correlate with improved glycemia (glucose levels measured in mg/dL) in the eTRE arm
Measure of change fasting beta-hydroxybutyrate levels in the eTRE arm relative to the UPF arm between Days 1, 8, and 15.
Time frame: Day 1 through Day 15
Plan to share: Yes — Individual participant data that underlie the results reported in the published article after deidentification (text, tables, figures and appendices)
Supporting information: Study protocol, Sap, Icf
This study is terminated, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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