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Time-restricted Eating, Window Timing, Type 2 Diabetes Status and Sex on Glycemic Control

ClinicalTrials.gov IDNCT06118931

PhaseNA

Enrollment123

SponsorUniversity of Toronto

Age40 Years

SexALL

I'm interested View official listing

Conditions studied

Diabetes Mellitus, Type 2, Obesity, Prediabetic State, Hyperglycemia

About this study

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.

Interventions

Behavioral: Early (7:00 - 16:00) TRE — A standardized TRE Protocol where participants eat ad libitum between the hours of 7:00 to 16:00 for 7 days. On the 8th day, they will consume a meal replacement beverage at 7:00, and not consume anything else for two hours.
Behavioral: Mid (9:30 - 18:30) TRE — A standardized TRE Protocol where participants eat ad libitum between the hours of 9:30 to 18:30 for 7 days. On the 8th day, they will consume a meal replacement beverage at 9:30, and not consume anything else for two hours.
Behavioral: Late (12:00 - 21:00) TRE — A standardized TRE Protocol where participants eat ad libitum between the hours of 12:00 to 21:00 for 7 days. On the 8th day, they will consume a meal replacement beverage at 12:00, and not consume anything else for two hours.

Primary outcomes

Average 24-hour glucose total area under the curve (AUC) over 7 days (7 days)

Eligibility information

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 locations

Remote Ontario-wide, Toronto, Ontario Canada

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.