Effect of Weight & Insulin Sensitivity on Reproductive Function in PCOS: Studies in Skeletal Muscle & Adipose (PULSE-A)

Pennington Biomedical Research Center

Status: Terminated

Conditions: Polycystic Ovary Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT01775176

PBRC 11016-A

Details and patient eligibility

About

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).

Full 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.

Enrollment: 17 patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Enrolled in PULSE NCT01482286

Exclusion criteria

• Withdraw from PULSE NCT01482286

Trial design

17 participants in 1 patient group

Polycystic Ovary Syndrome

Description:

Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusiveBody mass index ≥ 25kg/m2History of irregular menstrual cycles (fewer than 8 regular cycles in the past year)Clinical and/or biochemical androgen excess (Free androgen index\>3.85 and/or hirsuitism rating ≥8)Anovulatory menstrual cycles (determined during screening)