Metabolic Syndrome in PCOS: Precursors and Interventions

Northwestern University97 enrolled

Overview

The purpose of this study is to investigate the metabolic effects of anti-androgens and oral contraceptive pills (OCPs), compared with placebo, in the treatment of women with PCOS. We hypothesized that controlling elevated androgen levels with either anti-androgens or OCPs would produce improvement in metabolic markers in PCOS women and would reduce their long term metabolic risk.

Polycystic ovary syndrome (PCOS) is one of the most common conditions of young women, and it is frequently associated with insulin resistance or metabolic syndrome (MBS). In addition, affected women have significantly elevated mean low-density lipoprotein (LDL) levels and an increased prevalence of at risk LDL levels, independent of obesity. We are directly testing the role of androgens in the metabolic abnormalities in PCOS by examining the impact of direct androgen receptor blockade by anti-androgen medications and indirect suppression of androgen production through suppression of leutinizing hormone (LH) with oral contraceptive pills (OCPs), compared with placebo, on visceral adiposity, circulating LDL levels, insulin secretion and sensitivity as measured by frequently-sampled IV glucose tolerance tests (FSIGT) and oral glucose tolerance tests (OGTT), resting energy expenditure, and maximal aerobic capacity measurement. Note: Originally there were 2 additional study arm, Metformin only and Metformin + Flutamide. These study arms were ultimately eliminated and were not included in analysis of baseline characteristics or endpoints.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

QUADRUPLE

Enrollment

Conditions

Polycystic Ovary Syndrome Metabolic Syndrome

Interventions

flutamideDRUG

250 mg twice daily

ethinyl estradiol 35 mcg and drospirenone 3 mgDRUG

one active pill per day for three weeks and then 1 sugar pill per day for one week

placeboOTHER

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 6 periods or fewer per year * Overweight * All ethnicities Exclusion Criteria: * Diabetes * Heart Disease * Chronic illness * Regular Smokers * Current use of Birth Control Pills, Patch, Ring, Depo

Locations (1)

Northwestern Memorial Hospital

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Change in Low-density Lipoprotein (LDL) Levels Over the Study Period

Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)

Time frame: 6 months

Change in High-density Lipoprotein (HDL) Levels During Study Period

Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)

Time frame: 6 months

Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI

Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)

Time frame: 6 months

Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period

Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)

Time frame: 6 months

Change in Disposition Index

Change in disposition index (DI, insulin secretion corrected for insulin secretion) as measured by frequently-sampled IV glucose tolerance test (DI at study endpoint - baseline DI)

Time frame: 6 months

Change in Resting Energy Expenditure (REE) Over the Study Period

Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)

Time frame: 6 months

Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period

Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)

Data from ClinicalTrials.gov

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