Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Heart and Stroke Foundation of Canada | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
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;
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Metformin | Active Comparator | metformin (1500mg/d) and placebo (olive oil capsule) |
|
| Fishoil and metformin | Experimental | metformin (1500mg/d) and fish oil (4000mg/d) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fish oil | Dietary Supplement | For 12 months |
| |
| Metformin |
| Measure | Description | Time Frame |
|---|---|---|
| Carotid intimal medial thickness | mm | 12 months |
| carotid plaque height | mm | 12 months |
| Left ventricular global longitudinal strain (LVGLS) | percent change in LVGLS | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Blood lipids | TG, LDL-C, HDL-C, non-HDL-C mmol/l | 12 months |
| ApoB-lipoproteins | apob48 and apoB100 mg/l | 12 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
-pregnancy, lactation
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Donna Vine, PhD | Contact | 780-492-4393 | dvine@ualberta.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Human Nutrition Research Unit - Li Ka Shing Health Research Center | Recruiting | Edmonton | Alberta | T6G 2E1 | Canada |
no plan
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D002318 | Cardiovascular Diseases |
| D050197 | Atherosclerosis |
| D058226 | Plaque, Atherosclerotic |
| D006332 | Cardiomegaly |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D020763 | Pathological Conditions, Anatomical |
Not provided
Not provided
| ID | Term |
|---|---|
| D005395 | Fish Oils |
| D008687 | Metformin |
| ID | Term |
|---|---|
| D009821 | Oils |
| D008055 | Lipids |
| D001645 | Biguanides |
| D006146 | Guanidines |
| D000578 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Drug |
12 months |
|
| Fish Oil and Metformin | Combination Product | 12 months |
|
| remnant-cholesterol | mmol/l | 12 months |
| Testosterone | nmol/l | 12 months |
| insulin | pmol/l | 12 months |
| glucose | mmol/l | 12 months |
| Mazankowski Alberta Heart Institute | Recruiting | Edmonton | Alberta | T6G-2B7 | Canada |
|
| University of Alberta Hospital - Division of Endocrinology | Recruiting | Edmonton | Alberta | T6G-2B7 | Canada |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006331 | Heart Diseases |
| D006984 | Hypertrophy |
| Amidines |
| D009930 | Organic Chemicals |