RecruitingNAINTERVENTIONAL

Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids

Every three minutes, someone in Canada is diagnosed with diabetes, mostly type 2. Although lowering 'bad cholesterol' (LDL) is good for heart health, some research shows that very low LDL levels might increase the risk of developing type 2 diabetes. This study wants to understand why this might happen and if omega-3 fatty acids, found in fish oil, could help. Researchers believe that if too much LDL cholesterol enters a person's fat tissue, it could make the fat tissue unhealthy and increase diabetes risk, especially in those who are overweight. Omega-3s might be able to correct this. This trial will test if omega-3 supplements can reduce type 2 diabetes risk factors in people who have normal cholesterol levels but may be affected by this process.

At a glance

Status

Recruiting

Phase

Sponsor

Institut de Recherches Cliniques de Montreal

Enrolment target

Start

19 Dec 2019

Estimated completion

31 May 2027

Type 2 Diabetes Inflammation Insulin Sensitivity/Resistance Fatty Acids, Omega-3

What is this study about?

You might already know that type 2 diabetes and heart disease often go hand-in-hand, and they share many common risk factors like age, weight, and lifestyle. It's a bit of a puzzle, but for the past ten years, scientists have noticed something unexpected: while having lower levels of 'bad' cholesterol (LDL) generally protects your heart, it seems that very low LDL levels might actually increase your chance of developing type 2 diabetes. This can happen whether LDL is lowered by common heart medications called statins, or if you're born with certain gene variations.

Scientists are still trying to figure out why this happens and if natural nutrients could help. They think that when LDL cholesterol is encouraged to enter the body's fat tissue more than usual, it can make that fat tissue unhealthy, which then increases the risk for type 2 diabetes, especially for people who are overweight. However, they also know that omega-3 fatty acids, which are found in fish oil, might be able to fix these problems in the fat tissue.

This study aims to discover two main things in 48 volunteers who have normal cholesterol levels. First, they want to see if people whose bodies allow more LDL into their fat tissue have a higher risk of developing type 2 diabetes. Second, they'll investigate if taking an omega-3 supplement from fish oil for six months can help reduce these diabetes risk factors. The goal is to find an affordable and widely available way to help prevent type 2 diabetes.

Key takeaways

New research suggests very low 'bad cholesterol' might increase type 2 diabetes risk.
This study explores why this happens and if omega-3 can help.
Participants will take a daily omega-3 supplement for 6 months.
The goal is to find an inexpensive way to prevent type 2 diabetes.
The study focuses on people with normal cholesterol levels.

Who may be eligible?

The study is looking for both men and women who have gone through menopause. Participants should be between 45 and 74 years old and have a body mass index (BMI) between 25 and 40, which generally means they are overweight or have obesity. You should not smoke, do less than two hours of planned exercise a week, and drink less than two alcoholic drinks a day.

However, you cannot take part if you have very high 'bad cholesterol' (LDL) or a high risk of heart problems that would need immediate treatment. You also can't participate if you've already had serious health issues like a stroke, heart attack, or any type of diabetes. Uncontrolled high blood pressure, cancer within the last three years, or untreated thyroid, kidney, or liver problems would also prevent you from joining. Conditions that affect blood clotting or certain long-term inflammatory diseases would also exclude you.

Finally, if you have claustrophobia, sleep apnea, seizures, or are already taking certain medications (like hormone replacement therapy (except stable thyroid hormone), certain mental health medications, blood thinners, or weight loss/cholesterol-lowering drugs), you wouldn't be able to join. You'd also be excluded if you're allergic to seafood, fish, or a local anaesthetic called Xylocaine, or if you already take more than 250mg of omega-3 supplements daily.

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 45 and 74 years old and a man or post-menopausal woman?
Is your BMI between 25 and 40?
Do you not smoke and do less than 2 hours of structured exercise weekly?
Have you never had type 1 or 2 diabetes?
Are you not taking certain medications like blood thinners or high-dose omega-3?
Are you not allergic to seafood, fish, or Xylocaine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, the study will last about 8 months. You'll be asked to take a daily omega-3 supplement (3.6 grams per day) for 6 months. The researchers will split participants into two groups based on how much 'bad cholesterol' (LDL) your body's fat tissue might take in. This will help them understand if omega-3 has a different effect depending on this factor. Throughout the study, you will have several visits to the clinic where researchers will take tests and measurements to see how your body is responding to the omega-3 supplement.

Potential risks and benefits

Participating in this study might help us understand new ways to prevent type 2 diabetes, which could benefit many people in the future. You would also receive a commonly available omega-3 supplement, which many people take for general health. However, like any study, there could be some risks, such as side effects from the omega-3 supplement or discomfort from blood tests. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Montreal Clinical Research Institute
Verified postcode
Montreal, Canada· Recruiting

Common questions

What are omega-3 fatty acids?

Omega-3 fatty acids are a type of healthy fat often found in fish oil. They are known for various health benefits.

What is 'bad cholesterol' (LDL)?

LDL stands for low-density lipoprotein, and it's often called 'bad cholesterol' because high levels can lead to plaque buildup in your arteries.

What is type 2 diabetes?

Type 2 diabetes is a common condition where your body either doesn't produce enough insulin or doesn't use insulin effectively, leading to high blood sugar levels.

Will I know which group I'm in?

The study details don't specify if you will know which group you are in (higher or lower LDL receptors). This is often done to keep the study unbiased.

What kind of tests will I have?

The study involves various tests, likely including blood tests, body measurements, and possibly other assessments to understand how omega-3 impacts your body.

How to find out more

Justine Fricher, MSc

justine.fricher@ircm.qc.ca 514-987-5500 Official trial record

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