Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose

Terminated

• Conditions: Polycystic Ovary Syndrome

• Registration Number: NCT01775176
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

The overall objective of this ancillary study is to obtain skeletal muscle and subcutaneous adipose tissue biopsies from women with polycystic ovary syndrome enrolled in the PULSE Study (NCT01482286).

Detailed Description

Muscle and adipose tissues will be appropriately collected and banked for future studies such as to measure expression of candidate genes involved with carbohydrate and fat oxidation and mitochondrial function by RT-PCR, protein content by western blot, enzyme activity by enzymatic assays and to perform functional studies under varying conditions (for example before and after treatment with insulin, testosterone, serum) to quantify insulin signaling and carbohydrate and fat oxidation in primary human cultures.

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2013-01-22
• Study First Submitted QC: 2013-01-22
• Study First Posted: 2013-01-24
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-23
• Last Update Posted: 2021-08-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 17

Inclusion Criteria

• Enrolled in PULSE NCT01482286

Exclusion Criteria

• Withdraw from PULSE NCT01482286

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Bio specimens for future research	10 years

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States