Metabolic Syndrome in PCOS: Precursors and Interventions

May 9, 2014 updated by: Andrea Dunaif, Northwestern University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 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

Enrollment (Actual)

97

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 3
Placebo
Other: placebo
Other Names:
  • sugar pill
EXPERIMENTAL: 1
oral contraceptive (35 mg ethinyl estradiol)
Drug: ethinyl estradiol 35 mcg and drospirenone 3 mg
one active pill per day for three weeks and then 1 sugar pill per day for one week
Other Names:
  • Yasmin
EXPERIMENTAL: 2
Flutamide 250 mg twice daily
Drug: flutamide
250 mg twice daily
Other Names:
  • Eulexin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Low-density Lipoprotein (LDL) Levels Over the Study Period
Time Frame: 6 months
Change in low-density lipoprotein (LDL) levels over the study period (LDL level at study endpoint - baseline LDL level)
6 months
Change in High-density Lipoprotein (HDL) Levels During Study Period
Time Frame: 6 months
Change in high-density lipoprotein (HDL) levels during study period (HDL level at study endpoint - baseline HDL)
6 months
Change in Visceral Adipose Tissue (VAT) Volume as Measured by MRI
Time Frame: 6 months
Change in visceral adipose tissue (VAT) volume as measured by MRI (VAT at study endpoint - baseline VAT)
6 months
Change in Fat Percentage as Measured by Dual-energy X-ray Absorptiometry (DEXA) Scan Over the Study Period
Time Frame: 6 months
Change in fat percentage as measured by DEXA scan over the study period (Fat percentage at study endpoint - baseline fat percentage)
6 months
Change in Disposition Index
Time Frame: 6 months
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)
6 months
Change in Resting Energy Expenditure (REE) Over the Study Period
Time Frame: 6 months
Change in resting energy expenditure (REE) over the study period (REE at study endpoint - baseline REE)
6 months
Change in Maximal Aerobic Exercise Capacity (VO2 Max) Over the Study Period
Time Frame: 6 months
Change in maximal aerobic exercise capacity (VO2 max) over the study period (VO2 max at study endpoint - baseline VO2 max)
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Andrea Dunaif, MD, Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (ACTUAL)

November 1, 2012

Study Completion (ACTUAL)

November 1, 2012

Study Registration Dates

First Submitted

February 5, 2007

First Submitted That Met QC Criteria

March 1, 2007

First Posted (ESTIMATE)

March 2, 2007

Study Record Updates

Last Update Posted (ESTIMATE)

June 6, 2014

Last Update Submitted That Met QC Criteria

May 9, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DK73411
  • R01DK073411 (NIH)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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