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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40+
SponsorUniversity of Toronto

About this trial

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

Qualifiers

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.

Disqualifiers

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

History of or referral for bariatric surgery

Weight loss >3% in the last 3 months

Taking antiobesity (weight loss) medications

Trial design

Treatments tested in this trial

  • Early (7:00 - 16:00) TRE
  • Mid (9:30 - 18:30) TRE
  • Late (12:00 - 21:00) TRE

Treatment groups

123 Participants
are divided into 4 treatment groups

Sponsors and collaborators

University of Toronto

Lead sponsor

Diabetes Canada

Collaborator

Wharton Medical Clinic

Collaborator