NCT01600833

Brief Summary

The purpose of this study is to study the association of serum ferritin and homocysteine levels with insulin resistance and metabolic syndrome in women with polycystic ovary syndrome The polycystic ovary syndrome (PCOS) is a common endocrine disease, affecting 5-10% of women with reproductive age. Insulin resistance and metabolic disturbance are well-known long-term consequence of women with PCOS. Recent evidence suggests that increased body iron might be involved in the pathogenesis of insulin-resistance disorders, furthermore, hyperhomocysteinemia is associated with an increased risk of atherosclerotic and thromboembolic disorder. The investigators plan to retrospectively review the medical records of female patients who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
539

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2012

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 17, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 7, 2013

Status Verified

November 1, 2013

Enrollment Period

1 year

First QC Date

May 15, 2012

Last Update Submit

November 6, 2013

Conditions

Keywords

PCOSFerritinHomocysteineInsulin ResistanceMetabolic Syndrome

Outcome Measures

Primary Outcomes (1)

  • Serum ferritin levels in obese and non-obese women.

    The pathogenesis of increased iron stores correlated with insulin resistance and metabolic syndrome among obese and non-obese premenopausal women was different. The hypertriglyceridemia in women with PCOS might be associated with iron metabolism.

    the patients have PCOS who visited the Reproductive Endocrinology Clinic at the WanFang Medical Center from Jan 1, 2008 to Nov 30, 2011.

Study Arms (2)

Obese women

BMI\>25

Non obese women

BMI\<25

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

You may qualify if:

  • female patients who had been performed with fully PCOS-related survey Who visited the Reproductive Endocrinology Clinic at the Wan Fang Medical Center at Taipei Medical University from Jan 1, 2008, to November 30, 2011.

You may not qualify if:

  • women who had been diagnosed with disorders of the uterus (e.g., Asherman's Syndrome, Mullerian agenesis), and chromosomal anomalies (e.g., Turner syndrome)
  • women who had menopause
  • women with inadequate clinical/biochemical records
  • women who had had ovarian cysts or ovarian tumors
  • women who took hormone, medicine for Diabetes and/or cardiovascular disease.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, 110, Taiwan

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeInsulin ResistanceMetabolic Syndrome

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

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

May 15, 2012

First Posted

May 17, 2012

Study Start

March 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

November 7, 2013

Record last verified: 2013-11

Locations