## Protocol Section
### Identification Module
**NCT ID:** NCT06424860

**Brief Title:** Fish Oil, Metformin and Heart Health in PCOS

**Official Title:** Dietary Fish Oil and Metformin Intervention for Heart Health in PCOS

#### Organization Study ID Info
**ID:** 00141704
#### Organization
**Class:** OTHER
**Full Name:** University of Alberta
### Status Module
#### Completion Date
**Date:** 2027-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-22

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-16

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2026-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-06-01

**Type:** ESTIMATED

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-22
**Type:** ACTUAL
**Study First Submit Date:** 2024-04-29
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Heart and Stroke Foundation of Canada

#### Lead Sponsor

**Class:** OTHER

**Name:** University of Alberta

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**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.

### Conditions Module

**Conditions:**

- PCOS

- Cardiovascular Disease

- Atherosclerotic Cardiovascular Disease

- Atherosclerotic Plaque

- Cardiac Hypertrophy

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- PARTICIPANT

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 146

**Type:** ESTIMATED

**Phases:**

- PHASE1

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** metformin (1500mg/d) and placebo (olive oil capsule)

**Intervention Names:**

- Drug: Metformin

**Label:** Metformin

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** metformin (1500mg/d) and fish oil (4000mg/d)

**Intervention Names:**

- Dietary Supplement: Fish oil

- Combination Product: Fish Oil and Metformin

**Label:** Fishoil and metformin

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Fishoil and metformin

**Description:** For 12 months

**Name:** Fish oil

**Type:** DIETARY_SUPPLEMENT

#### Intervention 2

**Arm Group Labels:**

- Metformin

**Description:** 12 months

**Name:** Metformin

**Type:** DRUG

#### Intervention 3

**Arm Group Labels:**

- Fishoil and metformin

**Description:** 12 months

**Name:** Fish Oil and Metformin

**Type:** COMBINATION_PRODUCT

### Outcomes Module

#### Primary Outcomes

**Description:** mm

**Measure:** Carotid intimal medial thickness

**Time Frame:** 12 months

**Description:** mm

**Measure:** carotid plaque height

**Time Frame:** 12 months

**Description:** percent change in LVGLS

**Measure:** Left ventricular global longitudinal strain (LVGLS)

**Time Frame:** 12 months

#### Secondary Outcomes

**Description:** TG, LDL-C, HDL-C, non-HDL-C mmol/l

**Measure:** Blood lipids

**Time Frame:** 12 months

**Description:** apob48 and apoB100 mg/l

**Measure:** ApoB-lipoproteins

**Time Frame:** 12 months

**Description:** mmol/l

**Measure:** remnant-cholesterol

**Time Frame:** 12 months

**Description:** nmol/l

**Measure:** Testosterone

**Time Frame:** 12 months

**Description:** pmol/l

**Measure:** insulin

**Time Frame:** 12 months

**Description:** mmol/l

**Measure:** glucose

**Time Frame:** 12 months

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 45 Years

**Minimum Age:** 25 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### IPD Sharing Statement Module

**Description:** no plan

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000020763

- Term: Pathological Conditions, Anatomical

- ID: D000001161

- Term: Arteriosclerosis

- ID: D000001157

- Term: Arterial Occlusive Diseases

- ID: D000014652

- Term: Vascular Diseases

- ID: D000006331

- Term: Heart Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

### Condition Browse Module - Browse Leaves

- ID: M26188

- Name: Atherosclerosis

- Relevance: HIGH

- As Found: Atherosclerotic Cardiovascular Disease

- ID: M10035

- Name: Hypertrophy

- Relevance: HIGH

- As Found: Hypertrophy

- ID: M29003

- Name: Plaque, Atherosclerotic

- Relevance: HIGH

- As Found: Atherosclerotic Plaque

- ID: M9420

- Name: Cardiomegaly

- Relevance: HIGH

- As Found: Cardiac Hypertrophy

- ID: M22519

- Name: Pathological Conditions, Anatomical

- Relevance: LOW

- As Found: Unknown

- ID: M4469

- Name: Arteriosclerosis

- Relevance: LOW

- As Found: Unknown

- ID: M4465

- Name: Arterial Occlusive Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M17400

- Name: Vascular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000050197

- Term: Atherosclerosis

- ID: D000006332

- Term: Cardiomegaly

- ID: D000006984

- Term: Hypertrophy

- ID: D000058226

- Term: Plaque, Atherosclerotic

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

- Abbrev: HB

- Name: Herbal and Botanical

### Intervention Browse Module - Browse Leaves

- ID: M11667

- Name: Metformin

- Relevance: HIGH

- As Found: Assessment

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

- ID: T242

- Name: Olive

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000008687

- Term: Metformin

### Misc Info Module

- Version Holder: 2024-05-31
