RecruitingRecruiting
Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control
NCT06118931 · University of Toronto
In plain English
Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.
Official title
The Impact of Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control
About this study
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 effects of three 9-h TRE window times (early: 7:00-16:00 h, mid: 9:30-18:30 h, delayed: 12:00-21:00 h) on real-time, free-living glycemic control. The second objective is to determine if type 2 diabetes status (type 2 diabetes versus prediabetes or moderate+ risk for type 2 diabetes aka at risk for type 2 diabetes) modifies the effect of eating window timing on glycemic control outcomes. The exploratory objectives include: 1) determine whether sex modifies TRE adherence or the effect of TRE on metabolic changes relative to control; and 2) to compare changes in dietary intake, body weight, and blood pressure within and between early, mid, and delayed TRE. We have the following hypotheses related to these objectives:
1. The early TRE window will result in the most favourable glycemic control outcomes but also the lowest participant acceptability followed by mid and delayed TRE.
2. There will be larger differences in glycemic control outcomes between the TRE window timings among those with type 2 diabetes compared to those at risk for type 2 diabetes.
3. TRE adherence and changes in glycemic control, and weight loss with all TRE window times (relative to control) will be higher in men vs women.
4. Energy, carbohydrate, and sugar intake, body weight, and blood pressure will decrease during TRE, but with no differences by window timing.
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.
Study design
Enrollment target: 123 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-06-28
Estimated completion: 2027-06-28
Last updated: 2026-06-30
Interventions
Behavioral: Early (7:00 - 16:00) TREBehavioral: Mid (9:30 - 18:30) TREBehavioral: Late (12:00 - 21:00) TRE
Primary outcomes
- • Average 24-hour glucose total area under the curve (AUC) over 7 days (7 days)
Sponsor
University of Toronto · other
With: Diabetes Canada, Wharton Medical Clinic
Contacts & investigators
ContactAmy A Kirkham, PhD · contact · amy.kirkham@utoronto.ca · 416-946-4069
ContactTeresita Gormaz Clinical Trial coordinator, MsC · contact · establish.study.kpe@utoronto.ca · +1-416-946-0036
InvestigatorAmy A. Kirkham, PhD · principal_investigator, University of Toronto
All locations (1)
Remote Ontario-wideRecruiting
Toronto, Ontario, Canada