Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome

NCT01150539 | Completed

• 1 other identifier: PBRC 26038
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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).

Conditions

Polycystic Ovary Syndrome; Obesity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging)

  Baseline and 16-weeks

Study Arms (1)

Overweight/obese women with PCOS

EXPERIMENTAL

10 overweight/obese women with polycystic ovary syndrome

Other: 16-week exercise training program; Other: Control Group without PCOS

Interventions

16-week exercise training program OTHER

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.

Overweight/obese women with PCOS

Control Group without PCOS OTHER

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.

Overweight/obese women with PCOS

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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).

Sponsors & Collaborators

• Pennington Biomedical Research Center: lead

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Obesity

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Leanne Readman, PhD

  Pennington Biomedical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 22, 2010
• First Posted: June 25, 2010
• Study Start: January 1, 2007
• Primary Completion: May 1, 2007
• Study Completion: June 1, 2007
• Last Updated: August 25, 2021

Record last verified: 2021-08

Locations

US (1)