๐ฌIn 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.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Individuals with previously diagnosed BMI โฅ 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
Leadership Sinai Centre for Diabetes
Toronto, Canada
๐ค 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.