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

This study is currently recruiting participants.
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

April 3, 2013
November 5, 2013
March 2013
February 2014   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01826357 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age
Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Retrospective
Not Provided
Not Provided
Probability Sample

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

Metabolic Cardiovascular Syndrome
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
700
February 2014
February 2014   (final data collection date for primary outcome measure)

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.
Female
13 Years to 48 Years
Yes
Not Provided
Taiwan
 
NCT01826357
Hsu2013-TMU-JIRB 201302002
Yes
Ming-I Hsu, Taipei Medical University WanFang Hospital
Taipei Medical University WanFang Hospital
Not Provided
Principal Investigator: Ming I Hsu, MD WanFang Medical Center at Taipei Medical University
Taipei Medical University WanFang Hospital
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP