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

Launched by INSTITUT DE RECHERCHES CLINIQUES DE MONTREAL · Jul 21, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating how certain factors related to cholesterol might affect the risk of developing type 2 diabetes (T2D) and whether omega-3 fatty acids, commonly found in fish oil, can help reduce that risk. Researchers have noticed that while lowering "bad cholesterol" (LDL) is good for heart health, it may also increase the chances of developing T2D. The study aims to understand if people with higher levels of LDL in their fat tissue are more likely to have risk factors for T2D and whether taking omega-3 supplements for six months can improve their condition.

To be eligible for this trial, participants should be men or post-menopausal women aged 45 to 74 with a body mass index (BMI) between 25 and 40, and they should not have diabetes or certain heart disease risk factors. Participants will be asked to take omega-3 supplements and will be monitored throughout the study. This research could lead to new ways to prevent diabetes using a simple, accessible supplement.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• 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 Criteria:
• • 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