RecruitingNAINTERVENTIONAL

Adipose Tissue Storage in the Rapid Remission of Hepatic and Cardiac Metabolic Dysfunction After Bariatric Surgery

Researchers are investigating how bariatric surgery, a type of weight loss operation, helps people with type 2 diabetes. Specifically, they want to understand if changes in how the body's fat tissue works (called 'adipose tissue') are directly responsible for putting type 2 diabetes into remission. Participants will either have type 2 diabetes or not, and all will undergo bariatric surgery. The study involves several hospital visits, both before and after surgery, where various tests will be conducted to measure how the body uses energy and fat. Some participants will also be given a substance called nicotinic acid during one visit to help researchers understand specific processes related to fat metabolism. The aim is to uncover the exact reasons why bariatric surgery is so effective for people with type 2 diabetes.

At a glance

Status

Recruiting

Phase

Sponsor

Université de Sherbrooke

Enrolment target

Start

01 Nov 2023

Estimated completion

01 May 2028

Diabetes Mellitus Type 2

What is this study about?

This study is designed to help us understand why bariatric surgery, a type of weight-loss operation, is so effective at putting type 2 diabetes into remission. Many people who have this surgery find their diabetes improves significantly, sometimes disappearing completely. Researchers believe that the way our body stores and uses fat might play a big part in this improvement, and they want to find out exactly how.

They're particularly interested in how fat tissue, which is often called 'adipose tissue,' changes after surgery. These changes might affect how the body handles sugar and energy. By studying these processes closely, scientists hope to learn more about the link between fat, metabolism, and type 2 diabetes, which could eventually lead to better treatments. The study will involve people with and without type 2 diabetes, all of whom are having bariatric surgery.

The information gathered from this study could be really important. If we can understand the key mechanisms behind diabetes remission after surgery, it might help us develop new and more targeted ways to treat or even prevent type 2 diabetes in the future, even for people who don't have surgery.

Key takeaways

Researchers are studying how weight loss surgery helps improve type 2 diabetes.
The study focuses on changes in body fat and how it affects metabolism.
Participants will have bariatric surgery and attend several long hospital visits.
Special scans and blood tests will measure how the body uses energy and fat.
The results could lead to new ways to treat or prevent type 2 diabetes.

Who may be eligible?

To join this study, you need to be between 18 and 65 years old and have a Body Mass Index (BMI) of 35 or higher. You'll also need to be having bariatric surgery. The study is open to people who have been diagnosed with type 2 diabetes, as well as those who don't have it, to compare how the body changes in both groups.

There are certain reasons why you might not be able to take part. For instance, if you are pregnant or breastfeeding, or if you are currently taking certain medications like insulin, some heart medicines, or specific drugs for cholesterol (fibrates or thiazolidinediones), you wouldn't be suitable. This is because these medications can affect the results of the study and would need to be temporarily stopped, which isn't always safe or possible.

You also can't join if you have serious heart, liver, or kidney problems, or other uncontrolled health issues. If you smoke or drink more than a couple of alcoholic drinks a day, or if you have an allergy to eggs, you wouldn't be able to participate. Also, if you've already taken part in a radiation-based research study in the last two years, or if you weigh over 200 kg (due to scanner limits), you wouldn't be eligible.

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 65 years old?
Is your Body Mass Index (BMI) 35 or higher?
Are you planning to have bariatric (weight loss) surgery?
Are you not pregnant or breastfeeding?
Are you not taking certain medications like insulin or specific heart/cholesterol drugs?
Do you not have severe heart, liver, or kidney problems?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll have a total of five visits, mostly at the hospital. These include an initial screening visit to check if you're suitable. Before your surgery, you'll have two longer visits, each lasting about 9 hours, spaced at least a week apart. During one of these visits, you'll be given a substance called nicotinic acid, which helps researchers understand how your body handles fats.

After your bariatric surgery, you'll have two more visits. One will be about 12 days after your operation, and the final one will be approximately one year later. Each of these post-surgery visits will also last for about 9 hours. During these long visits, you'll have a liquid meal, and the researchers will use special scans (like PET and MRI) and administer safe, very small amounts of tracers (which are special substances that help show how your body is working) to measure how your body processes fats and sugars.

The total duration of your active participation, from the first pre-surgery visit to the final post-surgery visit, will be about one year.

Potential risks and benefits

By taking part, you'll be contributing to important scientific research that could help improve treatments for type 2 diabetes in the future. You'll also receive careful monitoring of your health during the study visits. However, there are some potential risks. The study involves several medical procedures, including blood tests, taking a liquid meal, and having special scans that use small amounts of radiation (like PET scans) and strong magnetic fields (MRI scans). There's also the temporary use of nicotinic acid for some participants, which can have side effects like flushing or itching. While researchers take every precaution, there's always a small risk associated with any medical procedure or medication. You should discuss all potential risks and benefits with the study team. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

centre de recherche du CHUS
Verified postcode
Sherbrooke, Canada· Recruiting

Common questions

What is bariatric surgery?

Bariatric surgery is a type of weight loss surgery that helps people lose a significant amount of weight and can greatly improve health conditions like type 2 diabetes.

What is type 2 diabetes?

Type 2 diabetes is a condition where your body doesn't use insulin properly or can't make enough of it, leading to high sugar levels in your blood.

Why do I need to stay for 9 hours during some visits?

The long visits are needed to carefully track how your body processes food and energy over several hours after you've had a meal, using special scans and measurements.

What is nicotinic acid and why is it used?

Nicotinic acid (also known as niacin) is a vitamin, but in this study, it's used in a specific way to help researchers understand how your body handles fats. It helps them see how fat is released and used after a meal.

Will I get paid to participate?

The study information doesn't mention payment, but it's important to ask the study team if there is any compensation for your time or travel expenses.

How to find out more

Frédérique Frisch

frederique.frisch@usherbrooke.ca 1-819-346-1110 Official trial record

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