Actively Recruiting
Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids
Led by Institut de Recherches Cliniques de Montreal · Updated on 2026-03-12
48
Participants Needed
1
Research Sites
388 weeks
Total Duration
On this page
Sponsors
I
Institut de Recherches Cliniques de Montreal
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Men and post-menopausal women aged 45 to 74 years
- Body mass index (BMI) between 25 and 40 kg/m2
- Confirmed menopausal status (FSH 6 30 U/l)
- Non-smoker
- Sedentary lifestyle with less than 2 hours of structured physical exercise per week
- Low alcohol consumption: fewer than 2 alcoholic drinks per day
You will not qualify if you...
- Plasma LDL cholesterol greater than 3.5 mmol/L
- High cardiovascular disease risk (Framingham Risk Score 6 20%) requiring immediate lipid-lowering treatment
- History of cardiovascular events (stroke, heart attack, angina, heart failure)
- Systolic blood pressure over 140 mmHg or diastolic blood pressure over 90 mmHg
- Type 1 or type 2 diabetes or fasting glucose over 7.0 mmol/L
- Cancer diagnosis within the last 3 years
- Untreated or unstable thyroid disease
- Anemia with hemoglobin below 120 g/L
- Kidney dysfunction or plasma creatinine over 100 bmol/L
- Liver dysfunction with AST/ALT over 3 times normal
- Bleeding disorders
- Autoimmune or chronic inflammatory diseases
- Difficulties accessing veins
- Claustrophobia
- Sleep apnea
- Seizures
- Use of hormone replacement therapy (except stable thyroid hormone), corticosteroids, antipsychotics, psychoactive drugs, anticoagulants, adrenergic agonists, antihypertensives, weight-loss or lipid-lowering medications
- Substance abuse
- Taking more than 250 mg of omega-3 supplements daily
- Allergies to seafood, fish, or Xylocaine
- Unable to eat the high-fat meal components
- Noncompliance with study requirements or repeated testing cancellations
- Insufficient time to complete the 33-week study
- Exceeding annual radiation exposure limits
- Other medical or psychological conditions deemed inappropriate by the physician
AI-Screening
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Trial Site Locations
Total: 1 location
1
Montreal Clinical Research Institute
Montreal, Quebec, Canada, H2W 1R7
Actively Recruiting
Research Team
J
Justine Fricher, MSc
CONTACT
R
Rianne Mahiout, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
PREVENTION
Number of Arms
1
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