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

This study has been completed.
Sponsor:
Information provided by:
Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01150539
First received: June 22, 2010
Last updated: April 15, 2011
Last verified: April 2011
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"

Resource links provided by NLM:


Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp [ Time Frame: Baseline and 16-weeks ] [ Designated as safety issue: No ]
    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) [ Time Frame: Baseline and 16-weeks ] [ Designated as safety issue: No ]
    16-weeks of aerobic exercise training on total and free testosterone concentraions and frequency of menstruation, Body lipolysis, and visceral fat.


Estimated Enrollment: 20
Study Start Date: January 2007
Study Completion Date: June 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
No Intervention: Control Group without PCOS
10 overweight/obese control women matched for race, age and BMI
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 30 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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;

    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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01150539

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

No publications provided

Responsible Party: Leanne M. Redman, Ph.D./Principal Investigator, Pennington Biomedical Research Center/Assistant Professor Clinical Physiology
ClinicalTrials.gov Identifier: NCT01150539     History of Changes
Other Study ID Numbers: PBRC26038
Study First Received: June 22, 2010
Last Updated: April 15, 2011
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on November 24, 2014