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Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study'


Phase 3
20 Years
40 Years
Open (Enrolling)
Female
Polycystic Ovary Syndrome

Thank you

Trial Information

Effect of Weight and Insulin Sensitivity on Reproductive Function in Polycystic Ovary Syndrome: Studies in Skeletal Muscle and Adipose Tissue 'PULSE Ancillary Study'


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.


Inclusion Criteria:



- Enrolled in PULSE

Exclusion Criteria:

- Withdraw from PULSE

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change in skeletal muscle insulin resistance Pulsatility profile of Luteinizing Hormone (LH)

Outcome Time Frame:

Baseline, week 24

Safety Issue:

No

Principal Investigator

Leanne M Redman, Ph.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Pennington Biomedical Research Center

Authority:

United States: Institutional Review Board

Study ID:

PBRC11016-A

NCT ID:

NCT01775176

Start Date:

May 2012

Completion Date:

December 2014

Related Keywords:

  • Polycystic Ovary Syndrome
  • PCOS, Weight, Insulin Sensitivity, Reproductive Function
  • Polycystic Ovary Syndrome
  • Insulin Resistance

Name

Location
Pennington Biomedical Research Center Baton Rouge, Louisiana  70808