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Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome (POLY)

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ClinicalTrials.gov Identifier: NCT01150539
Recruitment Status : Completed
First Posted : June 25, 2010
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):

Study Description
Brief Summary:
The effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with Polycystic ovary syndrome (PCOS).

Condition or disease Intervention/treatment
Polycystic Ovary Syndrome Obesity Other: 16-week exercise training program Other: Control Group without PCOS

Detailed Description:
Young, overweight/obese women with PCOS along with age and BMI-matched healthy controls without PCOS will be enrolled in this study. Participants will have assessments of body composition (by DEXA), visceral and ectopic fat (by MR), ovarian parameters (follicle size and number, by MRI) insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), aerobic fitness (by VO2max test) and a fat biopsy performed across two clinic visits (1 outpatient visit, and 1 overnight stay). Participants in the control group will undergo these assessments once only, whereas participants in the PCOS Group will have these assessments twice, once at baseline and once following a 16 week supervised aerobic exercise program. Throughout the exercise program body weight will be measured weekly and menstrual cycle frequency will be documented on a calendar. Additionally, vital signs, weight, waist and hip circumferences will be measured and a fasting blood sample collected every 4 weeks.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"
Study Start Date : January 2007
Primary Completion Date : May 2007
Study Completion Date : June 2007

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Overweight/obese women with PCOS
10 overweight/obese women with polycystic ovary syndrome
Other: 16-week exercise training program
The primary objective of the study is to investigate the effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with PCOS.
Other: Control Group without PCOS
A group of overweight/obese women without PCOS will be enrolled as a control group and will be studied only once at baseline to allow for comparisons between the two study populations.

Outcome Measures

Primary Outcome Measures :
  1. Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp [ Time Frame: Baseline and 16-weeks ]
    16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp.

Secondary Outcome Measures :
  1. Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging) [ Time Frame: Baseline and 16-weeks ]
    16-weeks of aerobic exercise training on total and free testosterone concentraions and frequency of menstruation, Body lipolysis, and visceral fat.

Eligibility Criteria

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Ages Eligible for Study:   18 Years to 30 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Women between the ages of 18-30, inclusive.
  • BMI greater than or equal to 25.
  • Sedentary lifestyle - not currently exercising more than 60 minutes per week.
  • A medical diagnosis of polycystic ovary syndrome. The diagnosis will be compared with the most recent international criteria1. Together with irregular menses (fewer than 6 cycles per year), participants must also have at least one of the following characteristics;

    1. presence of polycystic ovaries on transvaginal ultrasound, >10 cysts, 2-8 mm in diameter (ultrasound will not be done in this study however; ultrasound reports will be used if available) and/or
    2. clinical manifestations (hirsutism) examined by the PI at the screening visit or biochemical evidence (elevated testosterone or free androgen index) of hyperandrogenism, determined by fasting blood sample collected during the screening visit.
  • Women enrolling for the non-PCOS control group are required to have regular menstrual cycles (one cycle per month).

Exclusion Criteria:

  • Individuals with a history of cardiovascular disease or an elevated blood pressure above 160/90 mmHg.
  • Individuals with a history of Diabetes (Type 1 or Type 2).
  • Individuals with a history of Kidney, Liver or Heart disease.
  • Individuals with untreated thyroid disease.
  • Individuals who smoke.
  • Individuals who exercise more than 60 minutes per week.
  • Individuals who use medications including contraceptives (medications used to treat thyroid disease are permitted).
  • Individuals with alcoholism or other substance abuse.
  • Individuals who are pregnant or lactating (breast feeding).
  • Individuals who become pregnant throughout the study will be excluded.
  • Individuals who are trying to become pregnant.
  • Control subjects will be excluded if they have irregular menses (fewer than 1 cycle per month).
  • Unable to complete approximately 60 minutes of medium intensity exercise per day (5 days per week) at the Pennington Health and Fitness Center (PCOS Group Only).
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01150539

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
Principal Investigator: Leanne Readman, PhD Pennington Biomedical Research Center
More Information

Responsible Party: Leanne Redman, Assistant Professor, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01150539     History of Changes
Other Study ID Numbers: PBRC 26038
First Posted: June 25, 2010    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Polycystic Ovary Syndrome
Pathologic Processes
Ovarian Cysts
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases