Cardiovascular Disease Clinical Trial
Official title:
Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
Verified date | June 2024 |
Source | University of Alberta |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Not yet recruiting |
Enrollment | 146 |
Est. completion date | December 30, 2027 |
Est. primary completion date | June 30, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 25 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Alberta | Heart and Stroke Foundation of Canada |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Carotid intimal medial thickness | mm | 12 months | |
Primary | carotid plaque height | mm | 12 months | |
Primary | Left ventricular global longitudinal strain (LVGLS) | percent change in LVGLS | 12 months | |
Secondary | Blood lipids | TG, LDL-C, HDL-C, non-HDL-C mmol/l | 12 months | |
Secondary | ApoB-lipoproteins | apob48 and apoB100 mg/l | 12 months | |
Secondary | remnant-cholesterol | mmol/l | 12 months | |
Secondary | Testosterone | nmol/l | 12 months | |
Secondary | insulin | pmol/l | 12 months | |
Secondary | glucose | mmol/l | 12 months |
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