Recruiting

Time-Restricted Eating

Sponsor:

Mount Sinai Hospital, Canada

Code:

NCT07272460

Conditions

Type 2 Diabetes

Overweight (BMI > 25)

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Time-restricted eating

Standard lifestyle

Study Details

Brief summary:

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.

Conditions

Type 2 Diabetes

Overweight (BMI > 25)

Study ID

NCT07272460

Start date

Feb 1, 2026

Status verified date

Sep, 2025

Completion date

Jul 31, 2029

Anticipated

Primary completion date

Mar 30, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

112 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: Standard lifestyle

Standard lifestyle recommendation as per Diabetes Canada Guidelines.

Interventions

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 \[where patients are encouraged to maintain regularity in timing and spacing of meals with no specific recommendation regarding hours of fasting\]

Primary outcome measure

  • Differences in baseline-adjusted Insulin-Secretion-Sensitivity Index-2 (ISSI-2) between the study groups. [ Time Frame: 52-weeks ]

Central Contacts and Locations

Central contacts

Caroline K Kramer, MD, PhD

+1-416-586-4800Caroline.Kramer@sinaihealth.ca

Locations

Leadership Sinai Centre for Diabetes

Recruiting

Toronto, Ontario, Canada, M5T3L9

Contacts

Kramer

+1416-586-4800Caroline.Kramer@sinaihealth.ca

More Information

Sponsor

Mount Sinai Hospital, Canada

Last update posted

Feb 11, 2026

Last verified

Sep, 2025

Keywords

  • Randomized controlled trial
  • Time-restricted eating
  • Intermittent fasting
  • Type 2 diabetes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Mount Sinai Hospital, Canada on 2026-02-11.