Metabolic Syndrome in PCOS: Precursors and Interventions
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to determine whether lowering insulin levels using a medication called metformin, and blocking the action of male hormones with the medication flutamide wil decrease central body fat, improve cholesterol levels or affect sugar handling in women with PCOS (Polycystic ovary syndrome) The effects of these medications will be compared to the effects of the oral contraceptive pill (OCP), Yasmin. |
---|---|
Condition | Polycystic Ovary Syndrome Metabolic Syndrome |
Intervention | Drug: Metformin Drug: flutamide Drug: drospirenone Other: placebo |
Phase | N/A |
Sponsor | Northwestern University |
Responsible Party | Northwestern University |
ClinicalTrials.gov Identifier | NCT00442689 |
First Received | February 5, 2007 |
Last Updated | November 5, 2012 |
Last verified | November 2012 |
Tracking Information[ + expand ][ + ]
First Received Date | February 5, 2007 |
---|---|
Last Updated Date | November 5, 2012 |
Start Date | July 2006 |
Estimated Primary Completion Date | November 2012 |
Current Primary Outcome Measures | Comparison of flutamide and metformin alone and in combination on cardiovascular disease risk factors after six months. [Time Frame: 6 months] [Designated as safety issue: No] |
Current Secondary Outcome Measures | Predictors of response such as baseline androgen levels, FFA levels, insulin sensitivity and genotype. [Time Frame: 6 months] [Designated as safety issue: No] |
Descriptive Information[ + expand ][ + ]
Brief Title | Metabolic Syndrome in PCOS: Precursors and Interventions |
---|---|
Official Title | Metabolic Syndrome in PCOS: Precursors and Interventions |
Brief Summary | The purpose of this study is to determine whether lowering insulin levels using a medication called metformin, and blocking the action of male hormones with the medication flutamide wil decrease central body fat, improve cholesterol levels or affect sugar handling in women with PCOS (Polycystic ovary syndrome) The effects of these medications will be compared to the effects of the oral contraceptive pill (OCP), Yasmin. |
Detailed Description | 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. |
Study Type | Interventional |
Study Phase | N/A |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) |
Condition |
|
Intervention | Drug: Metformin 850mg tablets, 1 tablet/day with food for one week. After one week, subjects will take 1 tablet twice a day with food for the rest of the sixth month study period. Other Names:
250 mg twice daily Other Names: EulexinDrug: drospirenone one active pill per day for three weeks and then 1 sugar pill per day for one week Other Names: YasminOther: placebo 1-3 per day for the first week and then 1-4 per day for the rest of the six month study period. Subjects may receive only placebo (arm 5) or placebo in addition to the drug(s) they receive. Other Names: sugar pill |
Study Arm (s) |
|
Recruitment Information[ + expand ][ + ]
Recruitment Status | Completed |
---|---|
Estimated Enrollment | 97 |
Estimated Completion Date | November 2012 |
Estimated Primary Completion Date | November 2012 |
Eligibility Criteria | 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 |
Gender | Female |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Not Provided |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT00442689 |
---|---|
Other Study ID Numbers | DK73411 |
Has Data Monitoring Committee | Yes |
Information Provided By | Northwestern University |
Study Sponsor | Northwestern University |
Collaborators | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
Investigators | Principal Investigator: Andrea Dunaif, MD Northwestern University |
Verification Date | November 2012 |
Locations[ + expand ][ + ]
Northwestern Memorial Hospital | Chicago, Illinois, United States, 60611 |
---|