Clinical trial · Interventional
Effects of Exercise for Overweight Women With Polycystic Ovary Syndrome
Effects of Physical Activity on Insulin Resistance and Adiposity in Polycystic Ovary Syndrome "Poly"
NCT01150539CI-TRIAL-00053529POLYcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The effects of a 16-week exercise training program on insulin resistance and adiposity in overweight/obese women with Polycystic ovary syndrome (PCOS).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Obesity | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 16-week exercise training program | Other | — | UNRESOLVED |
| Control Group without PCOS | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Overweight/obese women with PCOS
- description
- 10 overweight/obese women with polycystic ovary syndrome
- interventionNames
- Other: 16-week exercise training program
- Other: Control Group without PCOS
Primary outcomes (1)
- measure
- Change in Insulin sensitivity as measured by the euglycemic hyperinsulinemic clamp
- timeFrame
- Baseline and 16-weeks
- description
- 16-weeks of aerobic exercise training on: peripheral insulin sensitivity (euglycemic-hyperinsulinemic clamp) and catecholamines (microdialysis) during a euglycemic-hyperinsulinemic clamp.
Secondary outcomes (1)
- measure
- Change in adiposity (whole body measurement by dual x-ray absorptiometry and visceral measured by magnetic resonance imaging)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 30 Years
Show eligibility criteria text
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).
References
Publications (0)
Data not yet available
No reference posted for this study.