RecruitingNot ApplicableNCT04485871

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

White Adipose Tissue LDL Receptors and Omega-3 as Modulators of the Risk for Type 2 Diabetes in Subjects With Normal Plasma LDL Cholesterol


Sponsor

Institut de Recherches Cliniques de Montreal

Enrollment

48 participants

Start Date

Dec 19, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Every 3 minutes a new case of diabetes is diagnosed in Canada, mostly type 2 diabetes (T2D) increasing the risk for heart disease. T2D and heart disease share many common risk factors such as aging, obesity and unhealthy lifestyle. Paradoxically however, while lowering blood LDL, commonly known as "bad cholesterol", is protective against heart disease, research over the past 10 years have shown that the lower is blood LDL, the higher is the chance of developing T2D. This phenomena is happening whether blood LDL is lowered by a common drug against heart disease called Statins, or by being born with certain variations in genes, some of which are very common (\~80% of people have them). To date, it is unclear why lowering blood LDL is associated with higher risk for diabetes, and whether this can be treated naturally with certain nutrients. Investigators believe that lowering blood LDL by forcing LDL entry into the body tissue through their receptors promotes T2D. This is because investigators have shown that LDL entry into human fat tissue induces fat tissue dysfunction, which would promote T2D especially in subjects with excess weight. On the other hand, investigators have shown that omega-3 fatty acids (omega-3) can directly treat the same defects induced by LDL entry into fat tissue. Omega-3 is a unique type of fat that is found mostly in fish oil. Thus the objectives of this clinical trial to be conducted in 48 subjects with normal blood LDL are to explore if: 1. Subjects with higher LDL receptors and LDL entry into fat tissue have higher risk factors for T2D compared to subjects with lower LDL receptors and LDL entry into fat tissue 2. 6-month supplementation of omega-3 from fish oil can treat subjects with higher LDL receptors and LDL entry into fat tissue reducing their risk for T2D. This study will thus explore and attempt to treat a new risk factor for T2D using an inexpensive and widely accessible nutraceutical, which would aid in preventing T2D in humans.


Eligibility

Min Age: 45 YearsMax Age: 74 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether omega-3 fatty acid supplements can reduce risk factors for diabetes in overweight, sedentary, middle-aged people who have normal cholesterol levels. It focuses on people who may be at metabolic risk but are not yet being treated with medication. **You may be eligible if...** - You are a man or post-menopausal woman aged 45–74 - You are overweight or obese (BMI 25–40) - You are non-smoking, sedentary (less than 2 hours of structured exercise per week), and drink little alcohol - Your cholesterol is within the normal range **You may NOT be eligible if...** - Your LDL (bad) cholesterol is elevated above the 75th percentile - You have a high calculated risk of cardiovascular disease - You have had a prior stroke, heart attack, or serious cardiovascular event - You are currently taking cholesterol-lowering medication Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTOmega-3 fatty acids

Triple Strength Omega-3 from Webber Naturals; 4 oral softgels (600 mg EPA and 300 mg DHA / softgel)


Locations(1)

Montreal Clinical Research Institute

Montreal, Quebec, Canada

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NCT04485871


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