Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
TEA-TIME
Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
1 other identifier
interventional
112
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable type-2-diabetes
Started Feb 2026
Typical duration for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 29, 2025
CompletedFirst Posted
Study publicly available on registry
December 9, 2025
CompletedStudy Start
First participant enrolled
February 1, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2029
February 11, 2026
September 1, 2025
3.2 years
September 29, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups.
Baseline-adjusted beta-cell function at 52 weeks, measured by Insulin Secretion-Sensitivity Index-2 (ISSI-2).
52-weeks
Secondary Outcomes (2)
Differences in baseline-adjusted insulin resistance between the study groups
52-weeks
Differences in time in glucose target range between each study group
52-weeks
Other Outcomes (5)
Anthropometric measures
52-weeks
Additional measures of beta-cell function
52-weeks
Additional measures of insulin sensitivity
52-weeks
- +2 more other outcomes
Study Arms (2)
Time-restricted eating
EXPERIMENTALTime-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.
Standard lifestyle
ACTIVE COMPARATORStandard lifestyle recommendation as per Diabetes Canada Guidelines.
Interventions
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.
standard lifestyle recommendations as per Diabetes Canada guidelines \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Leadership Sinai Centre for Diabetes
Toronto, Ontario, M5T3L9, Canada
Related Publications (1)
Retnakaran M, Lessa VL, Kramer CK. Time restricted EAting for Type 2 diabetes and MEtabolic health: The TEA TIME trial study protocol. PLoS One. 2026 Mar 12;21(3):e0343494. doi: 10.1371/journal.pone.0343494. eCollection 2026.
PMID: 41818195DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 29, 2025
First Posted
December 9, 2025
Study Start
February 1, 2026
Primary Completion (Estimated)
March 30, 2029
Study Completion (Estimated)
July 31, 2029
Last Updated
February 11, 2026
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share