Time restricted EAting for Type 2 diabetes and MEtabolic health: The TEA TIME trial study protocol.
Matthew Retnakaran, Vittória L Lessa, Caroline K Kramer
https://pubmed.ncbi.nlm.nih.gov/41818195Actively Recruiting
Phase Not Applicable
Age: 18Years - 75Years
All Genders
ID07272460
Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
Led by Mount Sinai Hospital, Canada · Updated on 2026-02-11
112
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying time-restricted eating as a potential way to preserve pancreatic beta-cell function and improve blood sugar control in people with type 2 diabetes. This randomized controlled trial focuses on adults who have been diagnosed with type 2 diabetes within the last 10 years and have a body mass index (BMI) over 25. The study aims to evaluate whether limiting eating to a certain time window each day can help with metabolic health and diabetes management. Participants will be randomly assigned to one of two groups. One group will follow a time-restricted eating plan where they fast for 18 hours each day and eat only during a 6-hour window from 2 to 8 PM for 52 weeks. The other group will follow standard lifestyle recommendations based on Diabetes Canada guidelines, which encourage regular meal timing but do not specify fasting periods. Both groups will be monitored throughout the year-long study. During the study, participants will undergo assessments to measure their insulin secretion and sensitivity, insulin resistance, and the amount of time their blood sugar stays within target ranges. These measures will be compared between the two groups after 52 weeks. Participants’ weight stability, medication use, and adherence to the assigned eating plan will be tracked. Safety and metabolic health will be monitored throughout the trial, which is expected to continue until July 2029.
CONDITIONS
Brief Title
Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Individuals with BMI 25 kg/m2 or higher and type 2 diabetes diagnosed within the past 10 years
- Age between 18 and 75 years inclusive
- Stable weight over the past 12 weeks with less than 5% change (self-reported)
- Diabetes treatment limited to lifestyle changes or metformin, DPP-4 inhibitors, or SGLT2 inhibitors alone or in combination
- Ability to read and understand English
You will not qualify if you...
- Current use of insulin, glucagon-like peptide-1 receptor agonists, or sulfonylureas for diabetes
- Use of any other medications for weight loss
- Previous weight-loss surgery such as gastric bypass or gastric band
- History of any eating disorder
- Currently pregnant or breastfeeding
- Kidney dysfunction with estimated glomerular filtration rate below 25 ml/min
- New York Heart Association class II-IV heart failure
- Significant liver disease or elevated liver enzymes
- Cancer requiring treatment within the last 5 years except basal cell skin cancer
- Any other factor that may limit study adherence
- Participation in another diabetes or metabolic health research study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Outpatient Treatment
Duration - 52 weeks
Participants follow either a time-restricted eating schedule with 18 hours of fasting and a 6-hour eating window daily or standard lifestyle recommendations for diabetes management.
Regular visits for dietary counseling and assessments
Trial Site Locations
Total: 1 location
1
Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada, M5T3L9
Actively Recruiting
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Research Team
C
Caroline K Kramer, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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