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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06424860
Other study ID # 00141704
Secondary ID
Status Not yet recruiting
Phase Phase 1
First received
Last updated
Start date August 1, 2024
Est. completion date December 30, 2027

Study information

Verified date June 2024
Source University of Alberta
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Intervention

Dietary Supplement:
Fish oil
For 12 months
Drug:
Metformin
12 months
Combination Product:
Fish Oil and Metformin
12 months

Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
University of Alberta Heart and Stroke Foundation of Canada

Outcome

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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