Time-restricted eating for adults with type 2 diabetes and overweight
Time Restricted-eating and Metabolic Health in Patients With Type 2 Diabetes
NA · Mount Sinai Hospital, Canada · NCT07272460
This project will test whether limiting daily eating to a shorter time window helps adults with type 2 diabetes and BMI ≥25 improve blood sugar control and preserve insulin-producing cells.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 112 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Mount Sinai Hospital, Canada (other) |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT07272460 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults 18–75 with type 2 diabetes diagnosed within the past 10 years, BMI ≥25, stable weight, treated with lifestyle alone or with metformin, DPP-4 inhibitors, or SGLT2 inhibitors, and able to attend visits in Toronto.
Not a fit: Patients using insulin, GLP-1 receptor agonists, or sulfonylureas, those with significant renal dysfunction, advanced heart failure, prior bariatric surgery, active eating disorders, or who are pregnant are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, this approach could preserve beta-cell function and improve blood sugar control, potentially reducing medication needs and long-term complications.
How similar studies have performed: Smaller trials and pilot studies have shown that time-restricted eating can produce weight loss and modest improvements in glucose control, but its ability to preserve beta-cell function in people with type 2 diabetes is not yet well established.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes, Overweight, Randomized controlled trial, Time-restricted eating, Intermittent fasting, Type 2 diabetes