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

Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"

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

Study Overview

• Status: Completed
• Conditions: Obesity; Polycystic Ovary Syndrome
• Intervention / Treatment: 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 Type: Interventional
• Enrollment (Actual): 8
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70808
      • Pennington Biomedical Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 16-weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline and 16-weeks

Collaborators and Investigators

• Sponsor: Pennington Biomedical Research Center
• Investigators: Principal Investigator: Leanne Readman, PhD, Pennington Biomedical Research Center

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): May 1, 2007
• Study Completion (Actual): June 1, 2007

Study Registration Dates

• First Submitted: June 22, 2010
• First Submitted That Met QC Criteria: June 24, 2010
• First Posted (Estimate): June 25, 2010

Study Record Updates

• Last Update Posted (Actual): August 25, 2021
• Last Update Submitted That Met QC Criteria: August 23, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: PBRC 26038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No