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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)

Must not have

History of or referral for bariatric surgery

Weight loss >5% in the last 3 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 7 days

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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I am older than 18 years.

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I have type 2 diabetes or am at high risk for it.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had or am referred for weight-loss surgery.

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I have lost more than 5% of my weight in the last 3 months.

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My body weight is over 340lbs.

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I am currently taking medication to help me lose weight.

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I have been diagnosed with an eating disorder by a doctor.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 7 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~7 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 7 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Average 24-hour glucose over 7 days

Average daily nocturnal glucose over 7 evenings

Average daily time spent in hyperglycemia over 7 days

+5 more

Other study objectives

Blood pressure change

Dietary intake

Physical Activity

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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.

0 / 7Eligibility criteria met