Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome

Condition(s) targeted: Polycystic Ovary Syndrome

Intervention: Fenofibrate (Drug); Placebo (Other)

Phase: N/A

Status: Recruiting

Sponsored by: Lawson Health Research Institute

Official(s) and/or principal investigator(s):
Tisha Joy, MD FRCPC, Principal Investigator, Affiliation: St. Joseph's Health Care, Department of Medicine

Overall contact:
Tisha Joy, MD FRCPC, Phone: 519-646-6296, Email: tisha.joy@sjhc.london.on.ca

This is a prospective randomized, double-blind placebo-controlled trial of 6 months' duration evaluating the effect of fenofibrate (200 mg/day) in females with polycystic ovary syndrome and mild hypertriglyceridemia. The investigators primary objective will be to determine whether fenofibrate will reduce hepatic adiposity as measured using MRI, and our secondary outcomes will be to delineate the impact of fenofibrate on biochemical or clinical parameters for insulin resistance, cardiovascular disease, and reproductive status.

Official title: Effects of Fenofibrate on Metabolic and Reproductive Parameters in Polycystic Ovary Syndrome. A Randomized, Double-Blind, Placebo-Controlled Trial

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome: Hepatic adiposity as assessed using MRI

Secondary outcome:

Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI

Insulin resistance using HOMA-IR

Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D)

Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP)

Reproductive parameters (androgens, hirsutism)

Minimum age: 18 Years. Maximum age: 45 Years. Gender(s): Female.

Criteria:

Inclusion Criteria:

- premenopausal women ≥ 18 years

- diagnosis of PCOS based on the recent 2006 Androgen Excess Society criteria (modified

from Rotterdam 2003)

- waist circumference >88 cm

- fasting TG 2. 0 - 5. 0 mmol/L

- stable on any type of oral contraceptive for a minimum of 3-months

Exclusion Criteria:

- known contraindications for MRI

- pregnancy, lactation, desire to become pregnant

- participation in another clinical trial

- fasting TF level ≥ 5. 0 mmol/L

- AST or ALT > 2. 5 times upper limit of normal (ULN)

- creatinine kinase (CK) > 6x ULN

- creatinine > 115 μmol/L

- fasting glucose ≥ 7. 0 mmol/L and/or 2h glucose post oral glucose tolerance test

(OGTT) ≥ 11. 1 mmol/L or personal history of DM2

- personal history of renal disease, liver disease (except NAFLD), or heart disease

- body mass index (BMI) < 18 or > 40 kg/m²

- increased alcohol use (>9 standard drinks per week [standard drink = 12oz beer, 5oz

wine, or 1. 5oz spirits]) or drug use

- use of other hormonal contraception, growth hormone, glucocorticoids,

anti-diabetic/anti-dyslipidemia medications, or anabolic steroids.

Tisha Joy, MD FRCPC, Phone: 519-646-6296, Email: tisha.joy@sjhc.london.on.ca

St. Joseph's Health Care, London, Ontario N6A 4L6, Canada; Recruiting
Tisha Joy, MD FRCPC, Phone: 519-646-6296, Email: tisha.joy@sjhc.london.on.ca
Tisha Joy, MD FRCPC, Principal Investigator

Related publications:

Toda K, Okada T, Miyaura C, Saibara T. Fenofibrate, a ligand for PPARalpha, inhibits aromatase cytochrome P450 expression in the ovary of mouse. J Lipid Res. 2003 Feb;44(2):265-70. Epub 2002 Nov 4.

Wysocki J, Belowski D, Kalina M, Kochanski L, Okopien B, Kalina Z. Effects of micronized fenofibrate on insulin resistance in patients with metabolic syndrome. Int J Clin Pharmacol Ther. 2004 Apr;42(4):212-7.

Lee HJ, Choi SS, Park MK, An YJ, Seo SY, Kim MC, Hong SH, Hwang TH, Kang DY, Garber AJ, Kim DK. Fenofibrate lowers abdominal and skeletal adiposity and improves insulin sensitivity in OLETF rats. Biochem Biophys Res Commun. 2002 Aug 16;296(2):293-9.

Idzior-Walus B, Sieradzki J, Rostworowski W, Zdzienicka A, Kawalec E, Wójcik J, Zarnecki A, Blane G. Effects of comicronised fenofibrate on lipid and insulin sensitivity in patients with polymetabolic syndrome X. Eur J Clin Invest. 2000 Oct;30(10):871-8.

Yong QW, Thavintharan S, Cheng A, Chew LS. The effect of fenofibrate on insulin sensitivity and plasma lipid profile in non-diabetic males with low high density lipoprotein/dyslipidaemic syndrome. Ann Acad Med Singapore. 1999 Nov;28(6):778-82.

Starting date: December 2008
Last updated: January 4, 2011