Polycystic Ovary Syndrome
Conditions
Keywords
polycystic ovary syndrome, hepatic adiposity, diabetes, hormones, cardiovascular disease
Brief summary
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.
Interventions
DRUGFenofibrate
fenofibrate 200 mg daily for 6-months
OTHERPlacebo
Placebo match for 6 months
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hepatic adiposity as assessed using MRI | 6-months |
Secondary
| Measure | Time frame |
|---|---|
| Body composition using bioelectrical impedance analysis (BIA), anthropometry (skin-fold thickness measurement), and MRI | 6-months |
| Insulin resistance using HOMA-IR | 6 months |
| Biochemical parameters related to insulin resistance (adipocytokines, free fatty acids, 25-hydroxyvitamin D) | 6 months |
| Traditional and non-traditional cardiovascular risk factors (lipids, apolipoproteins, fibrinogen, PAI-1, CRP) | 6 months |
| Reproductive parameters (androgens, hirsutism) | 6 months |
Countries
Canada
Outcome results
None listed