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Search / Trial NCT06118931

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

Launched by UNIVERSITY OF TORONTO · Oct 31, 2023

Trial Information

Current as of August 19, 2025

Not yet recruiting

Keywords

Time Restricted Eating Type 2 Diabetes Obesity Glycemic Control

ClinConnect Summary

This clinical trial is studying a method called time-restricted eating (TRE) to see how it affects blood sugar control in people with obesity who have type 2 diabetes or are at risk for it. TRE involves eating all your meals within a certain time frame each day, which can last anywhere from 4 to 12 hours. During the rest of the day, participants can only drink water or other calorie-free beverages. The researchers want to find out if the timing of the eating window makes a difference in managing blood sugar levels and if there are any differences between men and women in how they respond.

To participate in this study, you must be over 18 years old, have a body mass index (BMI) between 30 and 50, and either have type 2 diabetes or be at risk for it. You’ll need access to a smartphone to help with the study. However, if you have certain health conditions, like a recent significant weight loss or are on specific diabetes medications, you may not be eligible. If you join the study, you can expect to follow a new eating schedule and monitor how it affects your blood sugar levels over time.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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:
  • 1. History of or referral for bariatric surgery
  • 2. Weight loss \>5% in the last 3 months
  • 3. Taking antiobesity (weight loss) medications
  • 4. Body weight \>340lbs
  • 5. Diagnosed 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 eating during \<12 hour period on 5 or more days/week
  • 8. Physician-diagnosed eating disorder

About University Of Toronto

The University of Toronto, a prestigious research institution, serves as a leading sponsor of clinical trials dedicated to advancing medical knowledge and improving patient care. With a commitment to innovation and excellence, the university fosters a collaborative environment that brings together multidisciplinary teams of experts in medicine, pharmacology, and public health. Through rigorous research methodologies and ethical standards, the University of Toronto aims to explore new therapies, assess treatment efficacy, and address critical health challenges, ultimately contributing to the global body of scientific knowledge and enhancing healthcare outcomes.

Locations

Toronto, Ontario, Canada

Patients applied

0 patients applied

Trial Officials

Amy A. Kirkham, PhD

Principal Investigator

University of Toronto

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported