Fish Oil, Metformin and Heart Health in PCOS
Recruiting · NCT06424860 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
Women with Polycystic Ovary Syndrome (PCOS) have high testosterone levels which is associated with altered insulin-glucose metabolism and an adverse blood lipid profile, predisposing them to the development of Type II Diabetes and Cardiovascular Disease (CVD). This study will investigate the use of dietary fish oil supplementation as a safe and effective intervention, and as an adjunct therapy to standard of care treatment with metformin to improve heart health, blood lipids and insulin-glucose metabolism in women with PCOS, and those with PCOS and Type 2 Diabetes.
Who can take part
Age range
25 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- diagnosis of PCOS
- overweight-obese (BMI \>25 kg/m2)
- elevated fasting plasma TG (\>150 mg/dL)
- and/or apoB48-remnant cholesterol lipoproteins (\>20 ug/ml)
- impaired insulin sensitivity (glucose 100-125 mg/dL and/or insulin \>15 (uM/ml), and may be diagnosed with T2D (blood glucose \>126 mg/dL).
Exclusion criteria
- pregnancy, lactation
Where it is running
3 locations listed.
- Human Nutrition Research Unit - Li Ka Shing Health Research Center - Edmonton, Alberta, Canada
- Mazankowski Alberta Heart Institute - Edmonton, Alberta, Canada
- University of Alberta Hospital - Division of Endocrinology - Edmonton, Alberta, Canada