Actively Recruiting
Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
Led by Mount Sinai Hospital, Canada · Updated on 2026-02-11
112
Participants Needed
1
Research Sites
182 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals with previously diagnosed BMI 25 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 will not qualify if you...
- 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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada, M5T3L9
Actively Recruiting
Research Team
C
Caroline K Kramer, MD, PhD
CONTACT
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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