Status:
RECRUITING
Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control
Lead Sponsor:
University of Toronto
Collaborating Sponsors:
Diabetes Canada
Wharton Medical Clinic
Conditions:
Diabetes Mellitus, Type 2
Obesity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will evaluate the effectiveness of time-restricted eating (TRE), which is a form of intermittent fasting. When performing TRE, individuals consume all of their calories within a specific ti...
Detailed Description
The overarching aim of this study is to evaluate the interactions between TRE window timing, type 2 diabetes status, and sex among individuals with obesity. The first objective is to compare the effec...
Eligibility Criteria
Inclusion
- Aged \>18 years
- Body mass index \>30 kg/m2 and \<50 kg/m2
- Have access to an Apple or Android cellphone with Bluetooth.
- Have type 2 diabetes or be at risk for type 2 diabetes (defined as high (33+) Canadian Diabetes Risk Score)
Exclusion
- Individuals with type 2 diabetes will be excluded if: (1) currently on \>3 monotherapies for diabetes, (2) have had diabetes therapy dosage changes \<3 months, (3) self-reported hemoglobin A1c \>9.0%, (4) taking exogenous insulin, or (5) taking sulfonylureas
- The following exclusion criteria applies to all potential participants:
- History of or referral for bariatric surgery
- Weight loss \>5% in the last 3 months
- Taking antiobesity (weight loss) medications
- Body weight \>340lbs
- Diagnosed cognitive disorder that precludes them from giving consent
- Inability or unwillingness to change their eating window to follow those prescribed in the study
- Currently eating during \<12 hour period on 5 or more days/week
- Physician-diagnosed eating disorder
Key Trial Info
Start Date :
June 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 28 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06118931
Start Date
June 28 2025
End Date
June 28 2027
Last Update
October 2 2025
Active Locations (1)
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1
Remote Ontario-wide
Toronto, Ontario, Canada