The University of Toronto is recruiting adults aged 40+ with or without Type 2 Diabetes to participate in a research study named ESTABLISH (Effects of Sex, eaTing window, And diaBetes on gLycemIc Status and Health). Participation is completed virtually and involves following a specific eating schedule for one week at a time, across six weeks total. This study is led by Dr. Amy Kirkham and funded by Diabetes Canada.
Study Goals
Our study focuses on time-restricted eating, which is a popular and simple form of intermittent fasting that involves eating only within a set time window, commonly 8-10 hours, followed by a water-only fast for the remaining hours of the day.
The primary purpose of this study is to determine if the time of day of following time-restricted eating impacts its effects on blood sugar control, blood pressure, and metabolism or how much patients can or like to follow time-restricted eating? Specifically, we will compare three 9-hour eating windows: 1) early morning (7am to 4pm), 2) midmorning (9:30am to 6:30pm) and 3) early afternoon (12pm to 9pm). By comparing different time-restricted eating patterns, we hope to identify approaches that are both effective and practical for long-term use in everyday life.
Are you Eligible?
You may be eligible to take part in this study if you:
- Live in Ontario with access to a Lifelabs location for an overnight fasted blood draw one time at the beginning of the study
- Are 40 years of age or older
- ONE (or more) of the following apply to you:
- diagnosed with type 2 diabetes and are not taking insulin or sulfonyureas
- have been diagnosed by a doctor with pre-diabetes
- have had a recent (within the past 12 months) hemoglobin A1c blood test result between 5.7% and 6.4% (you can often access your results online to check)
- have an elevated waist circumference (we can help you to measure this)
What Does the Study Involve?
This 6-week study is conducted entirely online and can be completed from anywhere in Canada. If you are eligible to participate, you will receive a study package containing tools to measure your blood pressure, blood sugar, weight, sleep, physical activity, and waist circumference throughout the duration of the study. A study team member will guide you through how to use each device during a virtual session before you begin. You will also be asked to complete brief online questionnaires and one fasting blood draw at a local LifeLabs (or similar blood draw clinic) at the start of the study. Then you will follow your normal eating habits for one week, follow time-restricted eating for one week and repeat this twice more for a total of ~6 weeks. You will be randomly assigned to follow a different eating schedule for each time-restricted eating week: eating all food and drinks with calories between 7am to 4pm, 9:30am to 6:30pm and 12pm to 9pm.
As a thank-you for your participation, you will be able to keep all the devices provided, including a Fitbit physical activity and sleep tracker, a digital smart scale, and a blood pressure monitor. You will also receive a $50 electronic gift card.
Want to Learn More? Contact Us!
If this sounds interesting and you would like to learn more about participating, the first step will be to complete a survey to determine if you meet the initial eligibility criteria for the study. If your responses suggest that you may be eligible, you will be asked to provide your first name, phone number, and an email address at the end of the survey and book a time to speak to a study team member by phone. During the phone call, the rest of the details of the study will be explained to you so that you can decide if you want to participate.