Status:
RECRUITING
Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids
Lead Sponsor:
Institut de Recherches Cliniques de Montreal
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Type 2 Diabetes
Inflammation
Eligibility:
All Genders
45-74 years
Phase:
NA
Brief 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, o...
Detailed Description
Type 2 (T2D) and cardiovascular disease (CVD) share many risk factors, whose accumulation over years lead to disease onset. However, while lowering plasma low-density lipoprotein cholesterol (LDLC) is...
Eligibility Criteria
Inclusion
- Men and post-menopausal women:
- Having a body mass index (BMI= 25-40 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
- Plasma LDL cholesterol \> 3.5 mmol/L (i.e. \> 75th percentile in a Canadian population).
- Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score) who would require immediate medical intervention by lipid-lowering agents.
- Prior history of cardiovascular events (like stroke, transient ischemic attack, myocardial infarction, angina, heart failure…)
- Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
- Type 1 or 2 diabetes or fasting glucose \> 7.0 mmol/L
- Prior history of cancer within the last 3 years
- Thyroid disease - untreated or unstable
- Anemia - Hb \< 120 g/L
- Renal dysfunction or plasma creatinine \> 100 µmol/L
- Hepatic dysfunction - AST/ALT \> 3 times normal limit
- Blood coagulation problems (i.e. bleeding predisposition)
- Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).Known history of difficulties accessing a vein
- Claustrophobia
- Sleep apnea
- Seizures
- Concomitant medications: Hormone replacement therapy (except thyroid hormone at a stable dose), systemic corticosteroids, anti-psychotic medications and psycho-active medication, anticoagulant or anti-aggregates treatment (Aspirin, NSAIDs, warfarin, coumadin..), adrenergic agonist, anti-hypertensive drugs, weight-loss medication, lipid lowering medication
- Known substance abuse
- Already taking more than 250 mg of omega-3 supplements (EPA/DHA) per day
- Allergy to seafood or fish
- Allergy to Xylocaine
- Unable to eat the components of the high fat meal (croissant, cheese, bacon, brownies)
- None compliance to the study requirements (i.e. not being fasting) or cancellation of the same scheduled testing visit more than once.
- Lack of time to participate in the full length of the study (33 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 :
December 19 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2025
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT04485871
Start Date
December 19 2019
End Date
October 31 2025
Last Update
May 23 2025
Active Locations (1)
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1
Montreal Clinical Research Institute
Montreal, Quebec, Canada, H2W 1R7