Clinical trial for Type 2 Diabetes
Official title Targeting Risk Factors for Diabetes in Subjects With Normal Blood Cholesterol Using Omega-3 Fatty Acids
ClinicalTrials.gov ID: NCT04485871
What this study is testing
- What it's testing
- The study wants to see whether people with normal cholesterol but high LDL receptor activity have higher diabetes risk, and if taking omega‑3 for six months can reduce that risk.
- Who it's for
- Adults with normal LDL cholesterol who have high LDL receptor activity in their fat tissue.
- What's involved
- Participants will take a daily fish‑oil supplement for six months, have blood tests and other measurements taken at the start and end of the study, and may have additional visits for monitoring.
- Time commitment
- The study lasts six months, with visits at the beginning and end for tests and follow‑up.
- Time commitment: about 4 weeks
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 45 to 74. Healthy volunteers may be eligible.
You may be able to join if
- 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)
You likely can't join if
- 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...
- 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
See the full eligibility criteria
- 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Montreal, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 4 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 45 years to 74 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Montreal, Quebec, Canada. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.