Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial (TEA-TIME)

February 9, 2026 updated by: Mount Sinai Hospital, Canada

Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes

Time-restricted eating - where no food is consumed over a period of time - has been shown to promote weight loss and improve cardio-metabolic function. In individuals with type 2 diabetes, it is also been shown to improve glucose control. The investigators propose a randomized controlled trial to determine whether time-restricted eating is an effective therapeutic strategy that can preserve pancreatic beta-cell function and improve glycemic control early in participants with type 2 diabetes.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

In this study, eligible patients with type 2 diabetes will be randomized to either time-restricted eating or standard lifestyle. The hypothesis under study is whether time-restricted eating can improve pancreatic beta-cell function.

Study Type

Interventional

Enrollment (Estimated)

112

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5T3L9

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals with previously diagnosed BMI ≥ 25 kg/m2 and type 2 diabetes within preceding 10 years.
  • Age 18 - 75 years inclusive
  • Stable weight over past 12 weeks (less than 5% change in body weight) (self-reported)
  • Diabetes treatment consisting of lifestyle only or metformin, dipeptidyl peptidase-4 (DPP-4) inhibitor, and sodium-glucose co-transporter 2 (SGLT2) inhibitors either as monotherapy or in combination.
  • Ability to read and understand English

Exclusion Criteria:

  • Current diabetes treatment with insulin, glucagon-like peptide-1 receptor agonists, and/or sulfonylureas.
  • Use of any other pharmacological treatment for weight-loss
  • Previous surgical treatment for weight loss such as gastric bypass or gastric band
  • Any history of eating disorder
  • Currently pregnant or lactating
  • Renal dysfunction as evidenced by estimated glomerular filtration rate < 25 ml/min by CKD-EPI Creatinine Equation
  • New York Heart Association class II-IV heart failure
  • Hepatic disease considered to be clinically significant (includes jaundice, chronic hepatitis, or previous liver transplant) or transaminases >2.5X the upper limit of normal
  • Malignant neoplasm requiring chemotherapy, surgery, radiation or palliative therapy within the previous 5 years (with the exception of basal cell skin cancer)
  • Any other factor likely to limit adherence to the study, in the opinion of the investigators
  • Concurrent participation in another research study relevant to diabetes and metabolic health

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Time-restricted eating
Time-restricted eating protocol consisting of time-restricted eating with 18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day.
Behavioral: Time-restricted eating
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.
Active Comparator: Standard lifestyle
Standard lifestyle recommendation as per Diabetes Canada Guidelines.
Behavioral: Standard lifestyle
standard lifestyle recommendations as per Diabetes Canada guidelines [where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting]

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.
Time Frame: 52-weeks
Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
52-weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Differences in baseline-adjusted insulin resistance between the study groups
Time Frame: 52-weeks
Baseline-adjusted insulin resistance at 52-weeks measured by HOMA-IR
52-weeks
Differences in time in glucose target range between each study group
Time Frame: 52-weeks
Time in glucose target range indicates the amount of time (in %) that glucose readings are within the defined target glucose range of 3.9-10.0 mmol/L.
52-weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anthropometric measures
Time Frame: 52-weeks
Differences in body weight (kg) between each study arm
52-weeks
Additional measures of beta-cell function
Time Frame: 52-weeks
Insulinogenic index/HOMA-IR.
52-weeks
Additional measures of insulin sensitivity
Time Frame: 52-weeks
Matsuda Index
52-weeks
Time above glucose target on isCGM
Time Frame: 52 weeks
Differences between each study arm in time-above target of 10 mmol/l (%) obtained by isCGM (FreeStyle Libre devices).
52 weeks
Additional anthropometric measures
Time Frame: 52 weeks
Differences in waist circumference between the study arms
52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mount Sinai Hospital, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2026

Primary Completion (Estimated)

March 30, 2029

Study Completion (Estimated)

July 31, 2029

Study Registration Dates

First Submitted

September 29, 2025

First Submitted That Met QC Criteria

November 26, 2025

First Posted (Actual)

December 9, 2025

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB # 0002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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