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

Primary Purpose

Polycystic Ovary Syndrome, Obesity

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
16-week exercise training program
Control Group without PCOS
Sponsored by
Pennington Biomedical Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Polycystic Ovary Syndrome

Eligibility Criteria

18 Years - 30 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Pennington Biomedical Research Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Overweight/obese women with PCOS

Arm Description

10 overweight/obese women with polycystic ovary syndrome

Outcomes

Primary Outcome Measures

Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp
16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp.

Secondary Outcome Measures

Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging)
16-weeks of aerobic exercise training on total and free testosterone concentraions and frequency of menstruation, Body lipolysis, and visceral fat.

Full Information

First Posted
June 22, 2010
Last Updated
August 23, 2021
Sponsor
Pennington Biomedical Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT01150539
Brief Title
Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome
Acronym
POLY
Official Title
Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pennington Biomedical Research Center

4. Oversight

Data Monitoring Committee
No

5. 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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome, Obesity

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Overweight/obese women with PCOS
Arm Type
Experimental
Arm Description
10 overweight/obese women with polycystic ovary syndrome
Intervention Type
Other
Intervention Name(s)
16-week exercise training program
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Control Group without PCOS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp
Description
16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp.
Time Frame
Baseline and 16-weeks
Secondary Outcome Measure Information:
Title
Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging)
Description
16-weeks of aerobic exercise training on total and free testosterone concentraions and frequency of menstruation, Body lipolysis, and visceral fat.
Time Frame
Baseline and 16-weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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; 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 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leanne Readman, PhD
Organizational Affiliation
Pennington Biomedical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pennington Biomedical Research Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States

12. IPD Sharing Statement

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Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome

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