RecruitingNAINTERVENTIONAL

Time Restricted-EAting for Type 2 Diabetes and MEtabolic Health: the TEA TIME Trial

This study, called 'TEA TIME', explores how a eating pattern called 'time-restricted eating' can help people with type 2 diabetes. Time-restricted eating means you only eat your meals within a set window of hours each day. Previous research suggests this type of eating might help with weight loss and improve how the body processes sugar. For people with type 2 diabetes, it could lead to better control of blood sugar levels. Researchers want to find out if this eating style can also protect the cells in the pancreas that produce insulin (beta-cells) and improve blood sugar control in people who have recently developed type 2 diabetes. Participants will be randomly assigned to either follow time-restricted eating or continue with their usual lifestyle.

At a glance

Status

Recruiting

Phase

Sponsor

Mount Sinai Hospital, Canada

Enrolment target

112

Start

01 Feb 2026

Estimated completion

31 Jul 2029

Type 2 Diabetes Overweight (BMI > 25)

What is this study about?

This study is called the 'TEA TIME' trial, and it's looking into how a particular eating pattern, called 'time-restricted eating,' might help people with type 2 diabetes. Time-restricted eating means you eat all your meals and snacks within a set period each day, and don't eat anything during the remaining hours. For example, you might choose to eat only between 10 AM and 6 PM. Studies have previously shown that this way of eating can help people lose a bit of weight and improve how their body handles sugar and other fats. For those with type 2 diabetes, there's also a suggestion it could lead to better control of blood sugar levels.

The main aim of this study is to see if time-restricted eating can be an effective way to manage type 2 diabetes early on. Specifically, the researchers want to find out if it can help the special cells in your pancreas (called beta-cells) that produce insulin. Protecting and improving the function of these cells is really important for managing type 2 diabetes. They also want to see if it leads to better overall blood sugar control for people taking part.

If you join, you'll be randomly put into one of two groups: one group will follow the time-restricted eating plan, and the other will continue with their usual lifestyle. By comparing these two groups, the researchers hope to understand if time-restricted eating is a helpful tool for people with type 2 diabetes.

Key takeaways

The study explores time-restricted eating for type 2 diabetes.
It aims to improve blood sugar control and protect insulin-producing cells.
Participants will be randomly assigned to time-restricted eating or usual lifestyle.
Close monitoring and regular check-ups are part of the study.
Participation is voluntary, and you can withdraw anytime.

Who may be eligible?

To be considered for this study, you need to be an adult between 18 and 75 years old. You must have been diagnosed with type 2 diabetes within the last 10 years and have a Body Mass Index (BMI) of 25 or more, which generally means you're considered overweight. Your weight should have been stable recently, without big changes in the last three months. Your diabetes treatment should currently be limited to lifestyle changes, metformin, or certain other specific diabetes medications (DPP-4 inhibitors or SGLT2 inhibitors), either alone or in combination. Also, you need to be able to read and understand English.

However, some things would mean you can't join. For example, if you are currently taking insulin, or other specific diabetes medications like glucagon-like peptide-1 receptor agonists or sulfonylureas, you wouldn't be eligible. The study also isn't suitable if you've had weight-loss surgery, have a history of eating disorders, are pregnant or breastfeeding, or have serious kidney or heart problems. If you've recently had certain types of cancer treatment, or are taking part in another diabetes-related research study, you also wouldn't be able to join. The researchers will discuss all these points with you to make sure the study is right for you.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you between 18 and 75 years old?
Have you been diagnosed with type 2 diabetes in the last 10 years AND are considered overweight (BMI of 25 or more)?
Is your current diabetes treatment metformin, or specific other drugs like DPP-4 or SGLT2 inhibitors (or lifestyle changes only)?
Are you NOT currently using insulin or certain other diabetes medications (like GLP-1 agonists or sulfonylureas)?
Are you NOT pregnant or breastfeeding, and do NOT have a history of eating disorders or serious kidney/heart conditions?
Can you read and understand English?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be randomly assigned to one of two groups. One group will follow a time-restricted eating plan, which means you'll eat all your meals and snacks within a specific window of hours each day. The other group will continue eating as they usually do. The study will involve regular check-ups and assessments at the study clinic over a period of time to monitor your health, blood sugar levels, and other relevant factors. These visits might include blood tests, body measurements, and discussions about your diet and well-being. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you before you agree to join. You won't be asked to change any medications you are taking unless advised by the study doctors, and this would only happen if it's considered safe and necessary for your health or the study.

Potential risks and benefits

Participating in this study might offer some potential benefits, such as receiving close medical monitoring for your type 2 diabetes and learning about a specific eating pattern that could help manage your blood sugar and weight. However, as with any study, there could be some risks. These might include minor discomfort from blood tests or slight changes in your daily routine if you're in the time-restricted eating group. You will be fully informed about all potential risks and benefits before deciding to take part. It's very important to remember that joining a study is always voluntary, and you have the right to withdraw at any time, for any reason, without it affecting your medical care.

Locations (1)

Leadership Sinai Centre for Diabetes
Verified postcode
Toronto, Canada· Recruiting

Common questions

What exactly is 'time-restricted eating'?

It means you only eat your food within a certain number of hours each day, and don't eat anything during the remaining hours. For example, you might eat only between 11 AM and 7 PM.

Will I have to change my diabetes medication for this study?

The study has specific rules about which medications you can be taking. If you are accepted, your current medications will be discussed, but you won't be asked to change them unless it's considered safe and necessary for the study or your health.

How long will I be in the study?

The exact duration of your participation will be fully explained to you by the study team, including how many visits you'll need to make and over what period.

Will I know if I'm doing time-restricted eating or not?

Yes, if you're in the group doing time-restricted eating, you will be given clear instructions on how to follow this eating pattern.

Can I leave the study if I change my mind?

Absolutely. Taking part is completely voluntary, and you can withdraw from the study at any point, for any reason, without it affecting your usual healthcare.

How to find out more

Caroline K Kramer, MD, PhD

caroline.kramer@sinaihealth.ca +1-416-586-4800 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.