NCT01775176

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
17

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 24, 2013

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

August 24, 2021

Status Verified

August 1, 2021

Enrollment Period

3.9 years

First QC Date

January 22, 2013

Last Update Submit

August 23, 2021

Conditions

Polycystic Ovary Syndrome

Keywords

PCOS, Weight, Insulin Sensitivity, Reproductive Function

Outcome Measures

Primary Outcomes (1)

  • Bio specimens for future research

    10 years

Study Arms (1)

Polycystic Ovary Syndrome

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)

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Overweight women with polycystic ovary syndrome. 20 - 40 years, inclusive Body mass index ≥ 25kg/m2 History 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)

You may qualify if:

  • Enrolled in PULSE NCT01482286

You may not qualify if:

  • Withdraw from PULSE NCT01482286

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pennington Biomedical Research Center

Baton Rouge, Louisiana, 70808, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Skeletal Muscle Subcutaneous Adipose Tissue

MeSH Terms

Conditions

Polycystic Ovary SyndromeBody WeightInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Leanne M Redman, Ph.D.

    Pennington Biomedical Research Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle Investigator

Study Record Dates

First Submitted

January 22, 2013

First Posted

January 24, 2013

Study Start

May 1, 2012

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

August 24, 2021

Record last verified: 2021-08

Locations

US(1)