NCT06118931 Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control
| NCT ID | NCT06118931 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Toronto |
| Condition | Diabetes Mellitus, Type 2 |
| Study Type | INTERVENTIONAL |
| Enrollment | 123 participants |
| Start Date | 2025-06-28 |
| Primary Completion | 2027-06-28 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 123 participants in total. It began in 2025-06-28 with a primary completion date of 2027-06-28.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 time window and then only consume water or other no calorie drinks the rest of the day. TRE is performed each day. There is no restriction on the quality or amount of food that people can consume during their eating window (ad libitum eating) with TRE, which can last anywhere from 4 to 12 hours. We are comparing three different 9-hour eating windows to determine whether the start and stop time of the eating window impact blood sugar control in individuals with obesity who also have or are at risk for type 2 diabetes. We also aim to determine if there are differences in the effects of the timing of eating window between males and females.
Eligibility Criteria
Inclusion Criteria: * Aged 40 years or older * Body mass index \<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 self-report of pre-diabetes, a recent (within 12 months) measure of HbA1c between 5.7 and 6.4%, waist circumference (WC) that is BMI specific; for women: BMI \>= 18.5-24.9, WC \>= 80cm; BMI \>= 25-29.9, WC \>= 90cm; BMI \>= 30-34.9, WC \>= 105cm; BMI \>= 35+, WC \>= 115cm; for men: BMI \>= 18.5-24.9, WC \>= 90cm; BMI \>= 25-29.9, WC \>= 100cm; BMI \>= 30-34.9, WC \>= 110cm; BMI \>= 35+, WC \>= 125cm. Exclusion Criteria: * Individuals with type 2 diabetes will be excluded if: (1) currently on \>2 monotherapies for diabetes, (2) have had diabetes therapy medication or 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: 1. History of or referral for bariatric surgery 2. Weight loss \>3% in the last 3 months 3. Taking antiobesity (weight loss) medications 4. Body weight \>390lbs 5. Diagnosed with severe cognitive disorder that precludes them from giving consent 6. Inability or unwillingness to change their eating window to follow those prescribed in the study 7. Currently consistently eating during \<11.5 hour period . 8. Physician-diagnosed eating disorder 9. Having a pacemaker or receiving dialysis. 10. Not having access to a Lifelabs location.
Contact & Investigator
Amy A. Kirkham, PhD
PRINCIPAL INVESTIGATOR
University of Toronto
Frequently Asked Questions
Who can join the NCT06118931 clinical trial?
This trial is open to participants of all sexes, aged 40 Years or older, studying Diabetes Mellitus, Type 2. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06118931 currently recruiting?
Yes, NCT06118931 is actively recruiting participants. Contact the research team at amy.kirkham@utoronto.ca for enrollment information.
Where is the NCT06118931 trial being conducted?
This trial is being conducted at Toronto, Canada.
Who is sponsoring the NCT06118931 clinical trial?
NCT06118931 is sponsored by University of Toronto. The principal investigator is Amy A. Kirkham, PhD at University of Toronto. The trial plans to enroll 123 participants.
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