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.
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
Behavioral: Exercise
Behavioral: Dietary Restriction
PhasePhase 3
SponsorPennington Biomedical Research Center
Responsible PartyPennington Biomedical Research Center
ClinicalTrials.gov IdentifierNCT01775176
First ReceivedJanuary 22, 2013
Last UpdatedNovember 27, 2013
Last verifiedNovember 2013

Tracking Information[ + expand ][ + ]

First Received DateJanuary 22, 2013
Last Updated DateNovember 27, 2013
Start DateMay 2012
Estimated Primary Completion DateDecember 2015
Current Primary Outcome Measures
  • Change in skeletal muscle insulin resistance Pulsatility profile of Luteinizing Hormone (LH) [Time Frame: Baseline, week 24] [Designated as safety issue: No]
  • Change in adipose tissue insulin resistance [Time Frame: Baseline, week 24] [Designated as safety issue: No]
Current Secondary Outcome MeasuresNot Provided

Descriptive Information[ + expand ][ + ]

Brief TitleEffect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome:Studies in Skeletal Muscle and Adipose Tissue
Official TitleEffect 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 TypeInterventional
Study PhasePhase 3
Study DesignAllocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment
ConditionPolycystic Ovary Syndrome
InterventionDrug: Metformin
Behavioral: Exercise
Behavioral: Dietary Restriction
Study Arm (s)
  • No Intervention: Control
  • Experimental: Metformin
  • Experimental: Dietary Restriction
  • Experimental: Exercise

Recruitment Information[ + expand ][ + ]

Recruitment StatusRecruiting
Estimated Enrollment52
Estimated Completion DateDecember 2015
Estimated Primary Completion DateAugust 2015
Eligibility Criteria
Inclusion Criteria:

- Enrolled in PULSE

Exclusion Criteria:

- Withdraw from PULSE
GenderFemale
Ages20 Years
Accepts Healthy VolunteersNo
ContactsContact: Erin Lejeune, B.S.
225-763-2706
erin.lejeune@pbrc.edu
Location CountriesUnited States

Administrative Information[ + expand ][ + ]

NCT Number NCT01775176
Other Study ID NumbersPBRC11016-A
Has Data Monitoring CommitteeNo
Information Provided ByPennington Biomedical Research Center
Study SponsorPennington Biomedical Research Center
CollaboratorsNot Provided
Investigators Principal Investigator: Leanne M Redman, Ph.D. Pennington Biomedical Research Center
Verification DateNovember 2013

Locations[ + expand ][ + ]

Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Contact: Erin Lejeune, B.S. | 225-763-2706 | erin.lejeune@pbrc.edu
Principal Investigator: Leanne M Redman, Ph.D.
Recruiting