The Impact of Time Restricted Eating on Type 2 Diabetes

NCT06887543 | Terminated

• 1 other identifier: JAL-1056
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Type 2 diabetes; Time restricted eating; Intermittent fasting

Outcome Measures

Primary Outcomes (1)

• 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).

  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

  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

  Day 1 through Day 15

Study Arms (2)

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.

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.

Other: Usual feeding pattern.

Interventions

Meal timing OTHER

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 eating

Usual feeding pattern. OTHER

Participant consumes usual diet ad lib without enforced fasting period for six days while on Usual Feeding Pattern arm.

Usual feeding pattern, with meals eaten ad lib

Time restricted eating OTHER

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.

Time restricted eating

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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%

Sponsors & Collaborators

• NYU Langone Health: collaborator
• Rockefeller University: lead

Study Sites (1)

The Rockefeller University Hospital

New York, New York, 10065, United States

Location

Related Publications (12)

• 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.

  PMID: 39759025 BACKGROUND

• Aleman 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.

  PMID: 29264516 BACKGROUND

• Bruno 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.

  PMID: 37216066 BACKGROUND

• Wilkinson 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.

  PMID: 31813824 BACKGROUND

• Sutton 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.

  PMID: 29754952 BACKGROUND

• Scheer 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.

  PMID: 19255424 BACKGROUND

• Sakai 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.

  PMID: 29375081 BACKGROUND

• Poggiogalle 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.

  PMID: 29195759 BACKGROUND

• Morris 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.

  PMID: 25870289 BACKGROUND

• McHill 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.

  PMID: 28877894 BACKGROUND

• Jones 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.

  PMID: 32729615 BACKGROUND

• Jamshed 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.

  PMID: 31151228 BACKGROUND

Related Links

• Research on the positive effect of Time Restricted Feeding (TRF) on hyperglycemia and glucose control.

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Intermittent Fasting

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Fasting; Feeding Behavior; Behavior

Study Officials

• Jose Aleman, MD, PhD

  The Rockefeller University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: March 12, 2025
• First Posted: March 20, 2025
• Study Start: May 29, 2025
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: January 20, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning one year after publication, no end date
• Access Criteria: Researchers who provide a methodologically sound proposal. Proposals should be sent to jaleman@rockefeller.edu. To gain access, data requesters will need to sign a data access agreement.

Locations

US (1)