Status:
COMPLETED
Omega-3 to Reduce Diabetes Risk in Subjects With High Number of Particles That Carry "Bad Cholesterol" in the Blood
Lead Sponsor:
May Faraj, PDt, PhD
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Type 2 Diabetes
Insulin Sensitivity/Resistance
Eligibility:
All Genders
45-74 years
Phase:
NA
Brief Summary
In this project, investigators explored the role of the particles that carry "bad cholesterol" in the blood (termed LDL) that are known to promote heart disease, in the promotion of type 2 diabetes (T...
Detailed Description
Diabetes-attributed deaths, mostly type 2 diabetes (T2D), total more than 40,000 per year, out of which 80% are secondary to cardiovascular disease and stroke. Research from the investigators' lab and...
Eligibility Criteria
Inclusion
- Men and post-menopausal women:
- Having a body mass index (BMI) \> 20 kg/m2
- Aged between 45 and 74 years
- Having confirmed menopausal status (FSH ≥ 30 U/l)
- Non-smoker
- Sedentary (less than 2 hours of structured physical exercise (ex: sports club) per week)
- Low alcohol consumption: less than 2 alcoholic drinks/day
Exclusion
- Subjects with elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score) who require immediate medical intervention by lipid-lowering agents OR who cannot be placed on a 4 weeks wash-out period from their lipid-lowering medication at screening (i.e. upon admission to IRCM clinic).
- Subjects with systolic blood pressure \> 160 mmHg or diastolic blood pressure \> 100 mmHg
- Prior history of cardiovascular events (like stroke, transient ischemic attack, myocardial infarction, angina, heart failure...)
- Prior history of cancer within the last 3 years
- Thyroid disease - untreated
- Type 1 or 2 diabetes or fasting glucose \> 7.0 mmol/L
- Claustrophobia
- Anemia - Hb \< 120 g/L
- Creatinine \> 100 μmol/L
- Hepatic dysfunction - AST/ALT \> 3 times normal limit
- Blood coagulation problems (i.e. bleeding predisposition)
- Autoimmune diseases
- Chronic inflammatory diseases
- Concomitant medications
- Hormone replacement therapy (except thyroid hormone at a stable dose)
- Systemic corticosteroids
- Anti-psychotic medications - psycho-active medication
- Anticoagulant treatment (Aspirin, NSAIDs, warfarin, coumadin..)
- Adrenergic agonist
- Anti-hypertensive
- Weight-loss
- Known substance abuse
- Allergy to seafood or fish
- Cancellation of the same scheduled testing visit, twice
- Lack of time to participate in the full length of the study (18 weeks)
- Have exceeded the annual total allowed radiation dose (like X-ray scans and/or tomography in the previous year or in the year to come) according to the physician's judgement.
- All other medical or psychological conditions deemed inappropriate according to the physician
Key Trial Info
Start Date :
September 5 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2020
Estimated Enrollment :
41 Patients enrolled
Trial Details
Trial ID
NCT04496154
Start Date
September 5 2013
End Date
February 24 2020
Last Update
February 11 2025
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