NCT01989039

Brief Summary

FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance、inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

August 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 21, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

November 20, 2013

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

November 20, 2013

Status Verified

November 1, 2013

Enrollment Period

9 months

First QC Date

October 21, 2013

Last Update Submit

November 19, 2013

Conditions

Outcome Measures

Primary Outcomes (1)

  • Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women.

    A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital.

Eligibility Criteria

Age13 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.

You may qualify if:

  • Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about insulin resistance, cardiovascular and inflammatory markers.

You may not qualify if:

  • women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, and chromosomal anomalies;
  • women who had had menarche less than 1 years before evaluation or who were older than 49;
  • women who received hormones or drugs for major medical diseases within three months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, 116, Taiwan

RECRUITING

Related Publications (2)

  • Shen SH, Shen SY, Liou TH, Hsu MI, Chang YC, Cheng CY, Hsu CS, Tzeng CR. Obesity and inflammatory biomarkers in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2015 Sep;192:66-71. doi: 10.1016/j.ejogrb.2015.06.022. Epub 2015 Jul 2.

  • Chen CI, Hsu MI, Lin SH, Chang YC, Hsu CS, Tzeng CR. Adiponectin and leptin in overweight/obese and lean women with polycystic ovary syndrome. Gynecol Endocrinol. 2015 Apr;31(4):264-8. doi: 10.3109/09513590.2014.984676. Epub 2014 Nov 25.

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin Resistance

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System DiseasesHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ming I Hsu, MD

    Taipei Medical University WanFang Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Taipei Medical University WanFang Hospital

Study Record Dates

First Submitted

October 21, 2013

First Posted

November 20, 2013

Study Start

August 1, 2013

Primary Completion

May 1, 2014

Study Completion

July 1, 2014

Last Updated

November 20, 2013

Record last verified: 2013-11

Locations