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Omega-3 Fatty Acids
Omega-3 Fatty Acids for Type 2 Diabetes Risk Factors
N/A
Recruiting
Led By May Faraj, PDt, PhD
Research Sponsored by Institut de Recherches Cliniques de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Men and post-menopausal women with a body mass index (BMI) of 25-40 kg/m2
Aged between 45 and 74 years
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 24 week
Awards & highlights
Study Summary
This trial is looking at whether lowering LDL cholesterol increases the risk for type 2 diabetes, and whether omega-3 fatty acids can help treat the same defects that are caused by LDL entry into fat tissue.
Who is the study for?
This trial is for sedentary adults aged 45-74 with a BMI of 25-40 who are non-smokers, drink little alcohol, and have normal blood LDL cholesterol. It's not for those allergic to seafood or fish, with recent cancer history, high cardiovascular risk needing immediate treatment, diabetes, severe hypertension, renal or liver dysfunction, certain medication use or other medical conditions that the physician finds unsuitable.Check my eligibility
What is being tested?
The study tests if omega-3 fatty acids from fish oil can reduce the risk of type 2 diabetes in people with higher LDL receptors and fat tissue entry. Participants will take omega-3 supplements for six months to see if it treats defects caused by LDL entering fat tissue.See study design
What are the potential side effects?
While not explicitly stated in the provided information, common side effects of taking omega-3 supplements may include a fishy aftertaste, upset stomach, loose stools and nausea. More serious side effects are rare but could involve increased bleeding tendency.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a man or post-menopausal woman with a BMI between 25-40.
Select...
I am between 45 and 74 years old.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 24 week
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 24 week
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Fasting white adipose tissue NLRP3 inflammasome activation
Secondary outcome measures
Body composition
Disposition index
Energy intake
+9 moreSide effects data
From 2017 Phase 4 trial • 413 Patients • NCT026421595%
Diarrhoea
5%
Urinary tract infection
2%
Arthralgia
2%
Bronchitis
1%
Angina unstable
1%
Ischaemic stroke
1%
Non-cardiac chest pain
1%
Pneumonia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Alirocumab 75 mg Q2W/Up to 150 mg Q2W
Usual Care
Trial Design
1Treatment groups
Experimental Treatment
Group I: Omega-3 fatty acidsExperimental Treatment1 Intervention
3.6 g EPA:DHA / day (2:1)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Omega-3 fatty acids
2018
Completed Phase 4
~2640
Find a Location
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,344 Previous Clinical Trials
26,453,369 Total Patients Enrolled
Institut de Recherches Cliniques de MontrealLead Sponsor
70 Previous Clinical Trials
10,320 Total Patients Enrolled
May Faraj, PDt, PhDPrincipal InvestigatorMontreal Clinical Research Institute/ University of Montreal
1 Previous Clinical Trials
41 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to seafood or fish.You do not exercise regularly (less than 2 hours of structured physical activity per week).I have diabetes or my fasting blood sugar is high.I have a condition that makes me bleed easily.I have had a heart attack, stroke, or other serious heart problems.You have a history of substance abuse.Your blood pressure is higher than 140/90.I have seizures.I cannot eat high-fat foods like croissants, cheese, bacon, or brownies.My thyroid condition is either untreated or not under control.My kidney function is impaired or my creatinine level is high.I am not on hormone therapy, steroids, antipsychotics, blood thinners, or specific heart and weight-loss drugs.I have not exceeded the safe limit for radiation exposure this year.I have a high risk of heart disease needing treatment to lower my cholesterol.I am a man or post-menopausal woman with a BMI between 25-40.You have low hemoglobin levels (Hb) less than 120 g/L.I have an autoimmune or chronic inflammatory condition like lupus or rheumatoid arthritis.I have had cancer in the past 3 years.You are confirmed to have reached menopause based on a hormone test result.My liver enzymes are more than three times the normal limit.You are afraid of being in small, enclosed spaces.You are allergic to Xylocaine.You do not smoke cigarettes.I take more than 250 mg of omega-3 supplements daily.You have had trouble getting blood drawn from your veins in the past.You drink less than 2 alcoholic drinks per day.I have been diagnosed with sleep apnea.I am between 45 and 74 years old.Your LDL cholesterol level is higher than 3.5 mmol/L.
Research Study Groups:
This trial has the following groups:- Group 1: Omega-3 fatty acids
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could I qualify for participation in this experimental research?
"Patients aged 45 to 74 with type 2 diabetes mellitus can apply for admittance into this clinical trial. This experiment has a limited capacity of 48 participants in total."
Answered by AI
What is the current sample size of this research initiative?
"Affirmative. Per the clinicaltrials.gov records, this experiment is searching for participants as of now and was initially published on December 19th 2019 with its last update being August 27 2021. A total of 48 volunteers need to be gathered at 1 site."
Answered by AI
Are participants currently being accepted for this trial?
"According to clinicaltrials.gov, recruitment for this trial is still ongoing with the initial post dated December 19th 2019 and a recent update on August 27th 2021."
Answered by AI
Is the age threshold for this research endeavor 35 and above?
"To be accepted into this investigation, participants must range between 45 and 74 years old. For those under 18 or over 65, there are 234 trials and 1416 studies respectively."
Answered by AI
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