Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial
NCT ID: NCT07272460
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
112 participants
INTERVENTIONAL
2025-12-01
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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.
Time-restricted eating
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.
Standard lifestyle
Standard lifestyle recommendation as per Diabetes Canada Guidelines.
Standard lifestyle
standard lifestyle recommendations as per Diabetes Canada guidelines \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]
Interventions
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Time-restricted eating
18 hours of fasting and 6 hour window of eating (between 2 to 8 PM) every day for 52 weeks.
Standard lifestyle
standard lifestyle recommendations as per Diabetes Canada guidelines \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Mount Sinai Hospital, Canada
OTHER
Responsible Party
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Locations
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Leadership Sinai Centre for Diabetes
Toronto, Ontario, Canada
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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REB # 0002
Identifier Type: -
Identifier Source: org_study_id
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