Fish Oil, Metformin and Heart Health in PCOS

Cardiovascular Disease Clinical Trial

Official title:

Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06424860
• Other study ID #: 00141704
• Status: Not yet recruiting
• Phase: Phase 1
• 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
• 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

Related Conditions & MeSH terms

• Atherosclerosis
• Atherosclerotic Cardiovascular Disease
• Atherosclerotic Plaque
• Cardiac Hypertrophy
• Cardiomegaly
• Cardiovascular Disease
• Cardiovascular Diseases
• Hypertrophy
• PCOS
• Plaque, Atherosclerotic

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