Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Time-restricted eating, Standard lifestyle.
- Who it may be relevant to
- Registry conditions: Type 2 Diabetes, Overweight (BMI > 25). Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
Overview
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.
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.
Interventions
- Behavioral Time-restricted eating
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks. - Behavioral Standard lifestyle
standard lifestyle recommendations as per Diabetes Canada guidelines \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]
Primary outcome measures
- Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups. [Time frame: 52-weeks]
Secondary outcome measures (2)
- Differences in baseline-adjusted insulin resistance between the study groups [Time frame: 52-weeks]
- Differences in time in glucose target range between each study group [Time frame: 52-weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Canada · 1 center
- Leadership Sinai Centre for Diabetes — Toronto
Publications
- 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 41818195
Identifiers
NCT: NCT07272460 · REB # 0002