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Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial

RecruitingNAAges 18 Years - 75 YearsAllMount Sinai Hospital, Canada
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Individuals with previously diagnosed BMI โ‰ฅ 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
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What it tests

  • Time-restricted eating
  • Standard lifestyle
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Where

1 site
Leadership Sinai Centre for Diabetes
Toronto, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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