Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome

Obesity Clinical Trial

— POLY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01150539
• Other study ID #: PBRC 26038
• Status: Completed
• Phase: N/A
• Start date: January 2007
• Est. completion date: June 2007

Study information

• Verified date: August 2021
• Source: Pennington Biomedical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 2007
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 30 Years

Eligibility

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).

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Pennington Biomedical Research Center	Baton Rouge	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Pennington Biomedical Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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