Time-restricted eating for adults with type 2 diabetes and overweight

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this randomized controlled trial, adults aged 18–75 with type 2 diabetes diagnosed within the past 10 years and BMI ≥25 will be randomized to a time-restricted eating schedule or to a standard lifestyle approach. The time-restricted eating arm will limit daily food intake to a defined eating window while the control arm will follow usual timing with lifestyle guidance. Primary outcomes include pancreatic beta-cell function and measures of glycemic control, with clinical visits and testing performed at the Leadership Sinai Centre for Diabetes in Toronto. People on insulin, GLP-1 receptor agonists, sulfonylureas, or with significant renal impairment, advanced heart failure, prior bariatric surgery, or a history of eating disorders are excluded.

Why it matters

Who can join: the full rules

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

Where it's running

• Leadership Sinai Centre for Diabetes
  Toronto, Ontario, Canada Recruiting

Study contacts

• Study coordinator: Caroline K Kramer, MD, PhD
• Email: Caroline.Kramer@sinaihealth.ca
• Phone: +1-416-586-4800

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.