Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome:Studies in Skeletal Muscle and Adipose Tissue
Overview[ - collapse ][ - ]
Purpose | The purpose of the study is to test in 52 overweight and obese women with polycystic ovary syndrome the effect of 6 months of treatment with either: exercise training, 25% dietary restriction or metformin in comparison to a control group receiving no intervention on the functions of the skeletal muscle and adipose tissue. |
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Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin Behavioral: Exercise Behavioral: Dietary Restriction |
Phase | Phase 3 |
Sponsor | Pennington Biomedical Research Center |
Responsible Party | Pennington Biomedical Research Center |
ClinicalTrials.gov Identifier | NCT01775176 |
First Received | January 22, 2013 |
Last Updated | November 27, 2013 |
Last verified | November 2013 |
Tracking Information[ + expand ][ + ]
First Received Date | January 22, 2013 |
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Last Updated Date | November 27, 2013 |
Start Date | May 2012 |
Estimated Primary Completion Date | December 2015 |
Current Primary Outcome Measures |
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Current Secondary Outcome Measures | Not Provided |
Descriptive Information[ + expand ][ + ]
Brief Title | Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome:Studies in Skeletal Muscle and Adipose Tissue |
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Official Title | Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study' |
Brief Summary | The purpose of the study is to test in 52 overweight and obese women with polycystic ovary syndrome the effect of 6 months of treatment with either: exercise training, 25% dietary restriction or metformin in comparison to a control group receiving no intervention on the functions of the skeletal muscle and adipose tissue. |
Detailed Description | The PULSE Ancillary study will last about 7 months. Participants will one or two additional procedures performed at baseline and during the week 24 testing. These procedures include a fat biopsy, a muscle biopsy or both. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment |
Condition | Polycystic Ovary Syndrome |
Intervention | Drug: Metformin Behavioral: Exercise Behavioral: Dietary Restriction |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 52 |
Estimated Completion Date | December 2015 |
Estimated Primary Completion Date | August 2015 |
Eligibility Criteria | Inclusion Criteria: - Enrolled in PULSE Exclusion Criteria: - Withdraw from PULSE |
Gender | Female |
Ages | 20 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Erin Lejeune, B.S. 225-763-2706 erin.lejeune@pbrc.edu |
Location Countries | United States |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01775176 |
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Other Study ID Numbers | PBRC11016-A |
Has Data Monitoring Committee | No |
Information Provided By | Pennington Biomedical Research Center |
Study Sponsor | Pennington Biomedical Research Center |
Collaborators | Not Provided |
Investigators | Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center |
Verification Date | November 2013 |
Locations[ + expand ][ + ]
Pennington Biomedical Research Center | Baton Rouge, Louisiana, United States, 70808 Contact: Erin Lejeune, B.S. | 225-763-2706 | erin.lejeune@pbrc.eduPrincipal Investigator: Leanne M Redman, Ph.D. Recruiting |
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