Atherosclerotic Cardiovascular Disease, Atherosclerotic Plaque, Cardiac Hypertrophy, Cardiovascular Disease, PCOS
Conditions
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.
Interventions
DIETARY_SUPPLEMENTFish oil
For 12 months
DRUGMetformin
12 months
COMBINATION_PRODUCTFish Oil and Metformin
12 months
Sponsors
Heart and Stroke Foundation of Canada
University of Alberta
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
25 Years to 45 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carotid intimal medial thickness | 12 months | mm |
| carotid plaque height | 12 months | mm |
| Left ventricular global longitudinal strain (LVGLS) | 12 months | percent change in LVGLS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Testosterone | 12 months | nmol/l |
| Blood lipids | 12 months | TG, LDL-C, HDL-C, non-HDL-C mmol/l |
| glucose | 12 months | mmol/l |
| insulin | 12 months | pmol/l |
| ApoB-lipoproteins | 12 months | apob48 and apoB100 mg/l |
| remnant-cholesterol | 12 months | mmol/l |
Countries
Canada
Contacts
Primary ContactDonna Vine, PhD
Outcome results
None listed