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Clinical Trial Details — Status: Unknown status

Administrative data

NCT number NCT01826357
Other study ID # Hsu2013-TMU-JIRB 201302002
Secondary ID
Status Unknown status
Phase N/A
First received April 3, 2013
Last updated November 5, 2013
Start date March 2013
Est. completion date February 2014

Study information

Verified date November 2013
Source Taipei Medical University WanFang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Description:

Definitions of the metabolic syndrome based on arbitrary cutoff points for several quantitative variables, where each variable is related linearly to cardiovascular risk. Even consensual definitions differ between international authorities and continue to change. Moreover, such cutoff s should be gender and ethic difference. Cluster analysis is a statistical method base on algorithms, which seek to minimize within-group variation and maximize between-group variation for the clustering variables. This technique is suitable for defining groups, reflecting the natural structure of data without relying on inappropriate arbitrary cutoffs. We conduct this retrospective study to review the medical records of female patients who visited our Reproductive Endocrinology Clinic from Jan. 1, 2009 to Dec. 31, 2012. Cluster analysis was performed in our studied cases to evaluate the correlation between clinical/biochemical characteristic and risk of metabolic risk in women with reproductive age.


Recruitment information / eligibility

Status Unknown status
Enrollment 700
Est. completion date February 2014
Est. primary completion date February 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 13 Years to 48 Years
Eligibility Inclusion Criteria:

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

Exclusion Criteria:

1. women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, and chromosomal anomalies;

2. women who had had menarche less than 1 years before evaluation or who were older than 49;

3. women who received hormones or drugs for major medical diseases within three months of blood sampling.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
Taiwan WanFang Medical Center at Taipei Medical University Taipei City

Sponsors (1)

Lead Sponsor Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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