Fish Oil, Metformin and Heart Health in PCOS

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexFemale
Age25-45
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Fish oil

    Dietary supplement

    For 12 months

  • Metformin

    Drug

    12 months

  • Fish Oil and Metformin

    Combination product

    12 months

Treatment groups

146 Participants
are divided into 2 treatment groups
Group A: MetforminActive comparator 1 intervention
Group B: Fishoil and metforminExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Carotid intimal medial thickness

mm

Time frame
12 months
2

carotid plaque height

mm

Time frame
12 months
3

Left ventricular global longitudinal strain (LVGLS)

percent change in LVGLS

Time frame
12 months

Secondary outcomes

1

Blood lipids

TG, LDL-C, HDL-C, non-HDL-C mmol/l

Time frame
12 months
2

ApoB-lipoproteins

apob48 and apoB100 mg/l

Time frame
12 months
3

remnant-cholesterol

mmol/l

Time frame
12 months
4

Testosterone

nmol/l

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Alberta

Lead sponsor

Heart and Stroke Foundation of Canada

Collaborator