Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids
- Conditions
- Type 2 DiabetesInflammationInsulin Sensitivity/ResistanceFatty Acids, Omega-3
- Registration Number
- NCT04485871
- Lead Sponsor
- Institut de Recherches Cliniques de Montreal
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria:<br><br>Men and post-menopausal women:<br><br> - Having a body mass index (BMI= 25-40 kg/m2)<br><br> - Aged between 45 and 74 years<br><br> - Having confirmed menopausal status (FSH = 30 U/l)<br><br> - Non-smoker<br><br> - Sedentary (less than 2 hours of structured physical exercise (ex: sports club) per<br> week)<br><br> - Low alcohol consumption: less than 2 alcoholic drinks/day<br><br>Exclusion Criteria:<br><br> - Plasma LDL cholesterol > 3.5 mmol/L (i.e. > 75th percentile in a Canadian<br> population).<br><br> - Elevated risk of cardiovascular disease (= 20% of calculated Framingham Risk Score)<br> who would require immediate medical intervention by lipid-lowering agents.<br><br> - Prior history of cardiovascular events (like stroke, transient ischemic attack,<br> myocardial infarction, angina, heart failure...)<br><br> - Systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg<br><br> - Type 1 or 2 diabetes or fasting glucose > 7.0 mmol/L<br><br> - Prior history of cancer within the last 3 years<br><br> - Thyroid disease - untreated or unstable<br><br> - Anemia - Hb < 120 g/L<br><br> - Renal dysfunction or plasma creatinine > 100 µmol/L<br><br> - Hepatic dysfunction - AST/ALT > 3 times normal limit<br><br> - Blood coagulation problems (i.e. bleeding predisposition)<br><br> - Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel,<br> Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).Known<br> history of difficulties accessing a vein<br><br> - Claustrophobia<br><br> - Sleep apnea<br><br> - Seizures<br><br> - Concomitant medications: Hormone replacement therapy (except thyroid hormone at a<br> stable dose), systemic corticosteroids, anti-psychotic medications and psycho-active<br> medication, anticoagulant or anti-aggregates treatment (Aspirin, NSAIDs, warfarin,<br> coumadin..), adrenergic agonist, anti-hypertensive drugs, weight-loss medication,<br> lipid lowering medication<br><br> - Known substance abuse<br><br> - Already taking more than 250 mg of omega-3 supplements (EPA/DHA) per day<br><br> - Allergy to seafood or fish<br><br> - Allergy to Xylocaine<br><br> - Unable to eat the components of the high fat meal (croissant, cheese, bacon,<br> brownies)<br><br> - None compliance to the study requirements (i.e. not being fasting) or cancellation<br> of the same scheduled testing visit more than once.<br><br> - Lack of time to participate in the full length of the study (33 weeks)<br><br> - Have exceeded the annual total allowed radiation dose (like X-ray scans and/or<br> tomography in the previous year or in the year to come) according to the physician's<br> judgement.<br><br> - All other medical or psychological conditions deemed inappropriate according to the<br> physician
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Fasting white adipose tissue NLRP3 inflammasome activation;Fasting white adipose tissue NLRP3 inflammasome activation
- Secondary Outcome Measures
Name Time Method Fasting plasma PCSK9 concentration;Fasting plasma PCSK9 concentration;White adipose tissue receptors for apoB-lipoproteins;White adipose tissue receptors for apoB-lipoproteins;White adipose tissue inflammation profile;White adipose tissue inflammation profile;White adipose tissue function ex vivo;White adipose tissue function ex vivo;Postprandial fat metabolism;Postprandial fat metabolism;Systemic inflammation;Systemic inflammation;Disposition index;Disposition index;Fatty acid profile in red blood cell phospholipid fraction;Fatty acid profile in red blood cell phospholipid fraction;Body composition;Body composition;Energy intake;Energy intake;Physical activity;Physical activity