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