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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01775176

Acronym

PULSE-A

Enrollment

Registered

2013-01-24

Start date

2012-05-31

Completion date

2016-04-30

Last updated

2021-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, Weight, Insulin Sensitivity, Reproductive Function

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

20 Years to 40 Years

Healthy volunteers

Inclusion criteria

* Enrolled in PULSE NCT01482286

Exclusion criteria

* Withdraw from PULSE NCT01482286

Design outcomes

Primary

Measure	Time frame
Bio specimens for future research	10 years

Countries

United States

Outcome results