Type 2 DiabetesPrediabetes (Insulin Resistance, Impaired Glucose Tolerance)Prediabetes / Type 2 DiabetesObesity & OverweightObesity and Diabetes Mellitus, Type 2
Investigational drug(s) / intervention(s)
Fish OilFish OilCorn oil control
Fish Oil: Four softgels of Carlson Elite EPA Gems taken orally per day (NPN 80079735, 1 g EPA/softgel)
Fish Oil: Four softgels of Carlson Elite DHA Gems taken orally per day (NPN 80079736, 1 g DHA/softgel)
Corn oil control: Four softgels of Carlson placebo taken orally per day (food-grade corn oil, 0 g EPA and DHA per softgel)
Study summary
The purpose of this clinical trial is to find out whether one type of fish oil works better than another at improving metabolic health in people who are at high risk of developing type 2 diabetes.
Some metabolic problems-such as difficulty controlling blood sugar, unhealthy particles that transport cholesterol in the blood, and poor fat tissue function-can increase the risk of type 2 diabetes. This study aims to determine whether different types of fish oil can:
1. Improve how well the body produces insulin and responds to it,
2. Improve the quality of the particles that carry "bad" cholesterol in the blood, and 3) Improve the health and function of participants' fat tissue.
To answer these questions, researchers will compare the effects of two types of fish oil: EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). These will be compared with corn oil, which is used as a placebo and does not contain EPA or DHA.
When included in this study, participants will:
A) Take softgel capsules containing EPA, DHA, or placebo (corn oil) every day for 12 weeks, B) Keep a daily log to record when they take their study softgels, and C) Visit the research unit six times, including one and a half days before and after the intervention, to complete specialized metabolic tests that are mostly only available in research settings.
Eligibility
Sex
ALL
Min age
40 Years
Max age
70 Years
Healthy volunteers
Accepted
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)
Primary outcome measure(s)
Change from baseline to 12 weeks in the disposition index — 12-weeks Disposition index calculated as first phase glucose-induced insulin secretion multiplied by insulin sensitivity measured during the Botnia clamp \[(ng C-peptide/mL)\*(mg dextrose/kg/min)/(µU insulin/mL)\]
Trial sites (1)
Facility
City
Region
Status
Institut de recherches cliniques de Montréal (IRCM)
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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