NCT01826357

Brief Summary

The metabolic syndrome (MetS) is a cluster of clinical indices that signals increased risk for cardiovascular disease and Type 2 diabetes. Women with polycystic ovary syndrome (PCOS) were associated with MetS and insulin resistance. Cluster analysis was a useful tool for identifying groups of women sharing similar metabolic risk factor patterns. Oligomenorrhea, hyperandrogenism and polycystic ovary morphology were the three major components of PCOS. Obesity is a main risk factor in metabolic syndrome. the investigators are interesting to evaluate the relationship between risk of metabolic syndrome and their clinical and/or biochemical characteristics in women with reproductive age. Design: Retrospective study; medical records reviewed. Participants and setting: The investigators retrospectively reviewed the medical records of female patients who visited our Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.

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
700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 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

March 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 3, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 8, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
Last Updated

November 6, 2013

Status Verified

November 1, 2013

Enrollment Period

11 months

First QC Date

April 3, 2013

Last Update Submit

November 5, 2013

Conditions

Keywords

metabolic syndromecluster analysisPCOS

Outcome Measures

Primary Outcomes (1)

  • metabolic syndrome

    We conduct this retrospective study by using cluster analysis, to investigate the relationship between metabolic complications and biochemical/clinical characteristics of endocrinologic dysfunction in women with reproductive age.

    Retrospectively reviewed the patients who visited Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.

Eligibility Criteria

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

Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.

You may qualify if:

  • Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.

You may not qualify if:

  • women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, 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 of blood sampling.

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 (1)

  • Tzeng CR, Chang YC, Chang YC, Wang CW, Chen CH, Hsu MI. Cluster analysis of cardiovascular and metabolic risk factors in women of reproductive age. Fertil Steril. 2014 May;101(5):1404-10. doi: 10.1016/j.fertnstert.2014.01.023. Epub 2014 Feb 15.

MeSH Terms

Conditions

Metabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Ming I Hsu, MD

    WanFang Medical Center at Taipei Medical University

    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

April 3, 2013

First Posted

April 8, 2013

Study Start

March 1, 2013

Primary Completion

February 1, 2014

Study Completion

February 1, 2014

Last Updated

November 6, 2013

Record last verified: 2013-11

Locations