Metabolic Syndrome in PCOS: Precursors and Interventions
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 LDL levels and an increased prevalence of at
risk LDL levels, independent of obesity. There is a genetic susceptibility to PCOS and we
have identified a major susceptibility gene or genetic element on chromosome 19p3.2 near the
insulin receptor gene that is linked and associated with the reproductive phenotype of
hyperandrogenemia. We have mapped the location of this variant (allele 8[A8]D19S884)to an
allele a dinucleotide repeat in intron 55 of the fibrillin 3 gene. We are directly testing
the role of androgens in the metabolic abnormalities in PCOS by examining the impact of
androgen receptor blockade, alone and in combination with insulin sensitization, on visceral
adiposity and circulating LDL levels. Further, we will determine whether A8 is associated
with differential responses to this intervention. We will use the pure antiandrogen,
flutamide, and the insulin-sensitizing agent, metformin. In short term studies, OCP(oral
contraceptive pill) decreased insulin sensitivity in women with PCOS. We have included a
standard therapy arm with diet and the OCP, Yasmin, order to assess its impact on metabolic
endpoints concurrently with the othe interventions so that the data will be directly
comparable.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Comparison of flutamide and metformin alone and in combination on cardiovascular disease risk factors after six months.
6 months
No
Andrea Dunaif, MD
Principal Investigator
Northwestern University
United States: Food and Drug Administration
DK73411
NCT00442689
July 2006
November 2012
Name | Location |
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Northwestern Memorial Hospital | Chicago, Illinois 60611 |