Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Taipei Medical University WanFang Hospital
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01826357
First received: April 3, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


Condition
Metabolic Cardiovascular Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age.

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • metabolic syndrome [ Time Frame: Retrospectively reviewed the patients who visited Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012. ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 700
Study Start Date: March 2013
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Detailed 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.

  Eligibility

Ages Eligible for Study:   13 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

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

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01826357

Locations
Taiwan
WanFang Medical Center at Taipei Medical University Recruiting
Taipei City, Taiwan, 116
Contact: Ming I Hsu, MD    886-2-2930-7930 ext 2508    hsumingi@yahoo.com.tw   
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming I Hsu, MD WanFang Medical Center at Taipei Medical University
  More Information

No publications provided by Taipei Medical University WanFang Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01826357     History of Changes
Other Study ID Numbers: Hsu2013-TMU-JIRB 201302002
Study First Received: April 3, 2013
Last Updated: November 5, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
metabolic syndrome
cluster analysis
PCOS

Additional relevant MeSH terms:
Metabolic Syndrome X
Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Disease
Pathologic Processes

ClinicalTrials.gov processed this record on September 16, 2014