Type 2 DiabetesEaT2DMNCT06887543
The Impact of Time Restricted Eating on Type 2 Diabetes
A study testing Meal timing, Time restricted eating and Usual feeding pattern. in people with Type 2 Diabetes, run by Rockefeller University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Meal timing, Time restricted eating and Usual feeding pattern.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 2 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2025to 4 Aug 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current use of anti-obesity medications (Ozempic, Mounjaro, Trulicity, Wegovy, Zepbound, Qsymia, Contrave, Saxenda, Victoza, Orlistat)
- Report history of Cirrhosis
- HIV positive
- Self-reported autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, psoriasis, etc.)
- Current use of steroids (inhalers are permissible)
- Currently pregnant
Show all 17Show fewer
- Smoked tobacco within the last 3 months
- Allergy to adhesive tape
- Skips breakfast
- Followed TRF or intermittent fasting in the last 2 weeks
- Shift or night worker
- Current use of insulin
- Current use of sulfonylureas
- Current use of glucagon-like peptide-1 (GLP-1) receptor agonists
- Hemoglobin A1c >8%
- Unable to sync smartphone with Bluetooth for scale data
- Any medical, psychological, or social condition that, in the opinion of the investigator, would jeopardize the health or well-being of the participant during any study procedures or the integrity of the data.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Rockefeller University Hospital
New York, New York, 10065
About this study
Official title: The Impact of Time Restricted Eating on Type 2 Diabetes Study
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.
Read the detailed description
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.
- Conditions
- Type 2 Diabetes
- Being tested
- Meal timing, Time restricted eating, Usual feeding pattern.
- Keywords
- Type 2 diabetes, Time restricted eating, Intermittent fasting
- Medical subject headings
- Diabetes Mellitus, Type 2, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meal timingOther
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.
Time restricted eatingOther
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.
Usual feeding pattern.Other
Participant consumes usual diet ad lib without enforced fasting period for six days while on Usual Feeding Pattern arm.
| Study group | Role | What they receive |
|---|---|---|
| Time restricted eating | Active comparator | 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. Receives: Other: Meal timing; Other: Time restricted eating |
| Usual feeding pattern, with meals eaten ad lib | Placebo comparator | 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. Receives: Other: Usual feeding pattern. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From Day 1-15 of study intervention.
Secondary outcomes (2)
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.
Measured: 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.
Measured: Day 1 through Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2025
- Study start29 May 2025
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Why it stopped: clinical facility could no longer support study conduct; loss of funding, PI left the institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rockefeller University
- Sponsor type
- University, hospital or other
- Collaborators
- NYU Langone Health
- Responsible party
- Principal investigator, Jose O. Aleman, MD PhD, Rockefeller University
- Investigators
- Jose Aleman, MD, PhD, Principal investigator, The Rockefeller University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06887543
- Sponsor's protocol ID
- JAL-1056
- Acronym
- EaT2DM
- Status last verified
- Jan 2026
- First submitted
- 12 Mar 2025
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlie the results reported in the published article after deidentification (text, tables, figures and appendices)
Publications
Bruno J, Walker JM, Nasserifar S, Upadhyay D, Ronning A, Vanegas SM, Popp CJ, Barua S, Aleman JO. Weight-neutral early time-restricted eating improves glycemic variation and time in range without changes in inflammatory markers. iScience. 2024 Nov 29;27(12):111501. doi: 10.1016/j.isci.2024.111501. eCollection 2024 Dec 20.
PubMed 39759025Aleman JO, Iyengar NM, Walker JM, Milne GL, Da Rosa JC, Liang Y, Giri DD, Zhou XK, Pollak MN, Hudis CA, Breslow JL, Holt PR, Dannenberg AJ. Effects of Rapid Weight Loss on Systemic and Adipose Tissue Inflammation and Metabolism in Obese Postmenopausal Women. J Endocr Soc. 2017 Apr 25;1(6):625-637. doi: 10.1210/js.2017-00020. eCollection 2017 Jun 1.
PubMed 29264516Bruno J, Verano M, Vanegas SM, Weinshel E, Ren-Fielding C, Lofton H, Fielding G, Schwack B, Chua DL, Wang C, Li H, Aleman JO. Body Weight and Prandial Variation of Plasma Metabolites in Subjects Undergoing Gastric Band-Induced Weight Loss. Obes Med. 2022 Aug;33:100434. doi: 10.1016/j.obmed.2022.100434. Epub 2022 Jul 1.
PubMed 37216066Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020 Jan 7;31(1):92-104.e5. doi: 10.1016/j.cmet.2019.11.004. Epub 2019 Dec 5.
PubMed 31813824Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
PubMed 29754952Scheer FA, Hilton MF, Mantzoros CS, Shea SA. Adverse metabolic and cardiovascular consequences of circadian misalignment. Proc Natl Acad Sci U S A. 2009 Mar 17;106(11):4453-8. doi: 10.1073/pnas.0808180106. Epub 2009 Mar 2.
PubMed 19255424Sakai R, Hashimoto Y, Ushigome E, Miki A, Okamura T, Matsugasumi M, Fukuda T, Majima S, Matsumoto S, Senmaru T, Hamaguchi M, Tanaka M, Asano M, Yamazaki M, Oda Y, Fukui M. Late-night-dinner is associated with poor glycemic control in people with type 2 diabetes: The KAMOGAWA-DM cohort study. Endocr J. 2018 Apr 26;65(4):395-402. doi: 10.1507/endocrj.EJ17-0414. Epub 2018 Jan 27.
PubMed 29375081Poggiogalle E, Jamshed H, Peterson CM. Circadian regulation of glucose, lipid, and energy metabolism in humans. Metabolism. 2018 Jul;84:11-27. doi: 10.1016/j.metabol.2017.11.017. Epub 2018 Jan 9.
PubMed 29195759Morris CJ, Yang JN, Garcia JI, Myers S, Bozzi I, Wang W, Buxton OM, Shea SA, Scheer FA. Endogenous circadian system and circadian misalignment impact glucose tolerance via separate mechanisms in humans. Proc Natl Acad Sci U S A. 2015 Apr 28;112(17):E2225-34. doi: 10.1073/pnas.1418955112. Epub 2015 Apr 13.
PubMed 25870289McHill AW, Phillips AJ, Czeisler CA, Keating L, Yee K, Barger LK, Garaulet M, Scheer FA, Klerman EB. Later circadian timing of food intake is associated with increased body fat. Am J Clin Nutr. 2017 Nov;106(5):1213-1219. doi: 10.3945/ajcn.117.161588. Epub 2017 Sep 6.
PubMed 28877894Jones R, Pabla P, Mallinson J, Nixon A, Taylor T, Bennett A, Tsintzas K. Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men. Am J Clin Nutr. 2020 Oct 1;112(4):1015-1028. doi: 10.1093/ajcn/nqaa192.
PubMed 32729615Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.
PubMed 31151228
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Time Restricted Eating on Type 2 Diabetes Study
- ClinicalTrials.gov ID
- NCT06887543
- Acronym / sponsor ID
- EaT2DM / JAL-1056
- Conditions
- Type 2 Diabetes
- Keywords
- Type 2 diabetes, Time restricted eating, Intermittent fasting
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: clinical facility could no longer support study conduct; loss of funding, PI left the institution
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Rockefeller UniversityUniversity, hospital or other
- Collaborators
- NYU Langone Health
- Study start
- 29 May 2025 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 20 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Time restricted eating | Active comparator | Other: Meal timing, Other: Time restricted eatingSelection 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. |
| Usual feeding pattern, with meals eaten ad lib | Placebo comparator | Other: Usual feeding pattern.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 may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- Current use of anti-obesity medications (Ozempic, Mounjaro, Trulicity, Wegovy, Zepbound, Qsymia, Contrave, Saxenda, Victoza, Orlistat)
- Report history of Cirrhosis
- HIV positive
- Self-reported autoimmune disease (rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease, ulcerative colitis, psoriasis, etc.)
- Current use of steroids (inhalers are permissible)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Meal timingParticipants 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. | Other | Time restricted eating |
| Time restricted eatingEating 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. | Other | Time restricted eating |
| Usual feeding pattern.Participant consumes usual diet ad lib without enforced fasting period for six days while on Usual Feeding Pattern arm. | Other | Usual feeding pattern, with meals eaten ad lib |
Primary outcome
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
Time frame: From Day 1-15 of study intervention.
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).
2 secondary outcomes
Diurnal and prandial variation of GLP-1 will correlate with improved glycemia (serum glucose measured in mg/dL) in the eTRE arm
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
Time frame: Day 1 through Day 15
Results and safety
The study was stopped early (reason given: clinical facility could no longer support study conduct; loss of funding, PI left the institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Background: PubMed 39759025Bruno J, Walker JM, Nasserifar S, Upadhyay D, Ronning A, Vanegas SM, Popp CJ, Barua S, Aleman JO. Weight-neutral early time-restricted eating improves glycemic variation and time in range without changes in inflammatory markers. iScience. 2024 Nov 29;27(12):111501. doi: 10.1016/j.isci.2024.111501. eCollection 2024 Dec 20.
- Background: PubMed 29264516Aleman JO, Iyengar NM, Walker JM, Milne GL, Da Rosa JC, Liang Y, Giri DD, Zhou XK, Pollak MN, Hudis CA, Breslow JL, Holt PR, Dannenberg AJ. Effects of Rapid Weight Loss on Systemic and Adipose Tissue Inflammation and Metabolism in Obese Postmenopausal Women. J Endocr Soc. 2017 Apr 25;1(6):625-637. doi: 10.1210/js.2017-00020. eCollection 2017 Jun 1.
- Background: PubMed 37216066Bruno J, Verano M, Vanegas SM, Weinshel E, Ren-Fielding C, Lofton H, Fielding G, Schwack B, Chua DL, Wang C, Li H, Aleman JO. Body Weight and Prandial Variation of Plasma Metabolites in Subjects Undergoing Gastric Band-Induced Weight Loss. Obes Med. 2022 Aug;33:100434. doi: 10.1016/j.obmed.2022.100434. Epub 2022 Jul 1.
- Background: PubMed 31813824Wilkinson MJ, Manoogian ENC, Zadourian A, Lo H, Fakhouri S, Shoghi A, Wang X, Fleischer JG, Navlakha S, Panda S, Taub PR. Ten-Hour Time-Restricted Eating Reduces Weight, Blood Pressure, and Atherogenic Lipids in Patients with Metabolic Syndrome. Cell Metab. 2020 Jan 7;31(1):92-104.e5. doi: 10.1016/j.cmet.2019.11.004. Epub 2019 Dec 5.
- Background: PubMed 29754952Sutton EF, Beyl R, Early KS, Cefalu WT, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves Insulin Sensitivity, Blood Pressure, and Oxidative Stress Even without Weight Loss in Men with Prediabetes. Cell Metab. 2018 Jun 5;27(6):1212-1221.e3. doi: 10.1016/j.cmet.2018.04.010. Epub 2018 May 10.
- Background: PubMed 19255424Scheer FA, Hilton MF, Mantzoros CS, Shea SA. Adverse metabolic and cardiovascular consequences of circadian misalignment. Proc Natl Acad Sci U S A. 2009 Mar 17;106(11):4453-8. doi: 10.1073/pnas.0808180106. Epub 2009 Mar 2.
- Background: PubMed 29375081Sakai R, Hashimoto Y, Ushigome E, Miki A, Okamura T, Matsugasumi M, Fukuda T, Majima S, Matsumoto S, Senmaru T, Hamaguchi M, Tanaka M, Asano M, Yamazaki M, Oda Y, Fukui M. Late-night-dinner is associated with poor glycemic control in people with type 2 diabetes: The KAMOGAWA-DM cohort study. Endocr J. 2018 Apr 26;65(4):395-402. doi: 10.1507/endocrj.EJ17-0414. Epub 2018 Jan 27.
- Background: PubMed 29195759Poggiogalle E, Jamshed H, Peterson CM. Circadian regulation of glucose, lipid, and energy metabolism in humans. Metabolism. 2018 Jul;84:11-27. doi: 10.1016/j.metabol.2017.11.017. Epub 2018 Jan 9.
- Background: PubMed 25870289Morris CJ, Yang JN, Garcia JI, Myers S, Bozzi I, Wang W, Buxton OM, Shea SA, Scheer FA. Endogenous circadian system and circadian misalignment impact glucose tolerance via separate mechanisms in humans. Proc Natl Acad Sci U S A. 2015 Apr 28;112(17):E2225-34. doi: 10.1073/pnas.1418955112. Epub 2015 Apr 13.
- Background: PubMed 28877894McHill AW, Phillips AJ, Czeisler CA, Keating L, Yee K, Barger LK, Garaulet M, Scheer FA, Klerman EB. Later circadian timing of food intake is associated with increased body fat. Am J Clin Nutr. 2017 Nov;106(5):1213-1219. doi: 10.3945/ajcn.117.161588. Epub 2017 Sep 6.
- Background: PubMed 32729615Jones R, Pabla P, Mallinson J, Nixon A, Taylor T, Bennett A, Tsintzas K. Two weeks of early time-restricted feeding (eTRF) improves skeletal muscle insulin and anabolic sensitivity in healthy men. Am J Clin Nutr. 2020 Oct 1;112(4):1015-1028. doi: 10.1093/ajcn/nqaa192.
- Background: PubMed 31151228Jamshed H, Beyl RA, Della Manna DL, Yang ES, Ravussin E, Peterson CM. Early Time-Restricted Feeding Improves 24-Hour Glucose Levels and Affects Markers of the Circadian Clock, Aging, and Autophagy in Humans. Nutrients. 2019 May 30;11(6):1234. doi: 10.3390/nu11061234.
- Research on the positive effect of Time Restricted Feeding (TRF) on hyperglycemia and glucose control.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. Individual participant data that underlie the results reported in the published article after deidentification (text, tables, figures and appendices)
Related trials for Type 2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jose Aleman, MD, PhD principal investigator
The Rockefeller University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal timing, Time restricted eating and Usual feeding pattern. in people with Type 2 Diabetes, run by Rockefeller University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: clinical facility could no longer support study conduct; loss of funding, PI left the institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: From Day 1-15 of study intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06887543, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2026.