Clinical trial NCT06424860: Fish Oil, Metformin and Heart Health in PCOS
Official title: Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: PCOS
Cardiovascular Disease
Atherosclerotic Cardiovascular Disease
Atherosclerotic Plaque
Cardiac Hypertrophy
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2024-05-22
Enrollment: 146
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: OBJECTIVES The objective in this proposed study is to determine the effect of dietary fish oil supplementation with metformin compared to standard of care metformin-alone treatment for 12 months on plasma lipids and apoB- remnant lipoprotein metabolism, and atherosclerotic cardiovascular disease and cardiac function in high-risk overweight-obese young individuals with PCOS.

This study will provide evidence-based research on the efficacy of fish oil, in the form as an adjunct therapy to standard treatment with metformin, as a safe nutritional treatment to add to therapeutic guidelines to reduce early CVD risk in young women with PCOS.

Specific Objectives;

1. To quantify carotid intimal medical thickness (cIMT) and plaque height before and after the intervention to assess the effect of fish oil supplementation combined with metformin standard of care on atherosclerotic cardiovascular disease and cardiac function.
2. To determine the effects of dietary fish oil supplementation combined with metformin and metformin standard of care on fasting and non-fasting plasma TG, apoB48 and apoB100-lipoprotein concentrations, and cardiac function variables including left ventricular (LV) posterior wall thickness, LV ejection fraction.
3. To assess the effect of dietary fish oil supplementation on insulin, glucose, and endocrine parameters.

Eligibility criteria: 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

Primary outcomes:
measure: Carotid intimal medial thickness
timeFrame: 12 months
measure: carotid plaque height
timeFrame: 12 months
measure: Left ventricular global longitudinal strain (LVGLS)
timeFrame: 12 months
Secondary outcomes:
measure: Blood lipids
timeFrame: 12 months
measure: ApoB-lipoproteins
timeFrame: 12 months
measure: remnant-cholesterol
timeFrame: 12 months
measure: Testosterone
timeFrame: 12 months
measure: insulin
timeFrame: 12 months
measure: glucose
timeFrame: 12 months
Other outcomes:
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