Do different fish oils lower diabetes risk factors in people at high risk

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 2 interventional trial compares two types of fish oil, EPA and DHA, to corn oil in adults with BMI above 25 and high risk for type 2 diabetes. Participants will take softgels over a defined period to see how each oil type affects insulin production and sensitivity, LDL particle quality, and fat tissue health. The study uses a corn oil placebo to gauge relative effects. It aims to identify whether specific omega-3 fats can modify metabolic risk factors associated with diabetes development. The trial is conducted under supervision at the Institut de recherches cliniques de Montréal with collaboration from Diabetes Canada and Health Canada.

Why it matters

Who can join: the full rules

Inclusion Criteria:

Males and post-menopausal females:

* With a body mass index (BMI \>25-40 kg/m2)
* Having confirmed menopausal status (FSH ≥ 30 U/l)
* Non-smokers (tobacco) or have quitted for over a year
* Low-moderate alcohol consumption: \<7 alcoholic servings/ week
* Plasma apoB ≥1.05 g/L

Exclusion Criteria:

* Elevated risk of cardiovascular disease (≥ 20% of calculated Framingham Risk Score)
* Prior history of cardiovascular events (e.g. stroke, transient ischemic attack, myocardial infarction, angina, heart failure, arrhythmias, flutter, atrial …)
* Systolic blood pressure \> 140 mmHg or diastolic blood pressure \> 90 mmHg
* Diabetes or HbA1c ≥ 6.5%
* Reactive hypoglycaemia
* Prior history of cancer within the last 3 years or if lymph nodes were removed
* Thyroid disease - untreated or unstable Synthroid dose
* Severe renal dysfunction - eGFR \< 30 mL/min/1.73 m²
* Hepatic dysfunction - AST/ALT \> 3 times normal limit
* Anemia - Hb \< 120 g/L in females and \< 130 in males
* Bleeding disorders
* Blood coagulation problems (i.e. bleeding predisposition)
* Malabsorptive disease or surgeries (e.g. bariatric surgeries)
* Autoimmune and chronic inflammatory disease (i.e. celiac, inflammatory bowel, Graves, multiple sclerosis, psoriasis, rheumatoid arthritis, and lupus).
* Chronic diarrhea
* Cholecystectomy (e.g. removal of gall bladder)
* Sleep apnea
* Seizures
* Known history of difficulties accessing a vein
* Known history of vagal shock or loss of consciousness during blood withdrawal
* Concomitant medications (systemic corticosteroids; hypertension medication; anti-psychotic medications - psycho-active medication that promote weight gain; anticoagulant or anti-aggregates treatment (e.g. aspirin, NSAIDs, warfarin, coumadin..); systemic adrenergic agonists; weight-loss medication (e.g. GLP-1 agonists); lipid lowering medication (e.g. statins, anti-PCSK9); )
* Allergy to seafood/fish or corn oil
* Allergy to bovine gelatine or glycerine (softgel components)
* Allergy to Xylocaine (anesthesia used during fat tissue biopsy)
* Anticipated surgery or blood transfusion
* Known substance abuse
* Very high physical activity (\> 5 hours of aerobic exercise per week)
* Already taking more than 1 gm of EPA and/or DHA supplementation per day
* Lack of compliance to the study requirements (i.e. not being fasting)
* Cancellation of the same scheduled testing visit more than once
* Lack of time to participate in the full length of the study (18-22 weeks)
* Other conditions deemed inappropriate by the study physician (e.g. difficulties in understanding/communicating in French or English)

Where it's running

• Institut de recherches cliniques de Montréal (IRCM)
  Montreal, Quebec, Canada Recruiting

Study contacts

• Principal investigator: May Faraj, P.Dt., Ph.D. — Institut de recherches cliniques de Montréal (IRCM)/ Université de Montréal
• Study coordinator: Justine Fricher, M.Sc.
• Email: t2dresearch@ircm.qc.ca
• Phone: 514-987-5500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.