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Behavioural Intervention
Time-Restricted Eating for Type 2 Diabetes
N/A
Waitlist Available
Led By Amy A. Kirkham, PhD
Research Sponsored by University of Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Aged >18 years
Have type 2 diabetes or be at risk for type 2 diabetes (defined as high (33+) Canadian Diabetes Risk Score)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 7 days
Awards & highlights
Study Summary
This trial studies the effects of timing of eating on blood sugar in those with obesity and type 2 diabetes. Participants are assigned a 4-12hr eating window with no restrictions on the food they eat. Results will compare 3 9hr windows to determine if start and stop time impacts blood sugar.
Who is the study for?
This trial is for adults over 18 with obesity (BMI >30 and <50) who have type 2 diabetes or are at high risk for it. Participants must own a smartphone with Bluetooth. Exclusions include those on extensive diabetes treatments, recent medication changes, very high A1c levels, using insulin or certain drugs, significant recent weight loss, planned bariatric surgery, cognitive disorders affecting consent ability, eating disorders or unwillingness to adjust eating times.Check my eligibility
What is being tested?
The study tests the impact of time-restricted eating (TRE) on blood sugar control in obese individuals with or at risk for type 2 diabetes. It compares three different TRE schedules: early (7am-4pm), midday (9:30am-6:30pm), and late (12pm-9pm). The goal is to see if the timing affects glycemic control differently between men and women.See study design
What are the potential side effects?
Since this trial involves dietary changes rather than medication, side effects may include hunger outside of eating windows, potential headaches or irritability due to fasting periods, and possible adjustments in energy levels.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am older than 18 years.
Select...
I have type 2 diabetes or am at high risk for it.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 7 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~7 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Average 24-hour glucose total area under the curve (AUC) over 7 days
Secondary outcome measures
Average 24-hour glucose over 7 days
Average daily nocturnal glucose over 7 evenings
Average daily time spent in hyperglycemia over 7 days
+5 moreOther outcome measures
Blood pressure change
Dietary intake
Physical Activity
+3 moreTrial Design
4Treatment groups
Experimental Treatment
Active Control
Group I: Mid (9:30-18:30h) TREExperimental Treatment1 Intervention
Participants will be asked to eat ad libitum between the hours of 9:30 - 18:30 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 9:30 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.
Group II: Late (12:00-21:00h) TREExperimental Treatment1 Intervention
Participants will be asked to eat ad libitum between the hours of 12:00 - 21:00 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 12:00 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.
Group III: Early (7:00-16:00h) TREExperimental Treatment1 Intervention
Participants will be asked to eat ad libitum between the hours of 7:00 - 16:00 each day for seven days, and then only drink water or other no calorie beverages for the rest of the day. On the 8th day, they will consume one meal replacement beverage at 7:00 and be instructed to not consume anything else for two hours. After the two hours they will be instructed to return to their normal baseline eating habits.
Group IV: ControlActive Control1 Intervention
During the first week of the study, participants will be asked to eat as they normally do, and to not make any changes regarding when they are stopping or starting eating.
Find a Location
Who is running the clinical trial?
Wharton Medical ClinicUNKNOWN
1 Previous Clinical Trials
47 Total Patients Enrolled
University of TorontoLead Sponsor
690 Previous Clinical Trials
1,019,523 Total Patients Enrolled
Diabetes CanadaOTHER
10 Previous Clinical Trials
987 Total Patients Enrolled
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there an opportunity for enrolment in this experiment?
"According to clinicaltrials.gov, this particular study is not currently enrolling patients as the most recent update was made on October 31st 2023. Fortunately, there are 2477 other research initiatives actively seeking participants at this time."
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