MedDataX Logo

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

NCT ID: NCT01826357

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

700 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-03-31

Study Completion Date

2014-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Cardiovascular Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

metabolic syndrome cluster analysis PCOS

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Ming-I Hsu

Taipei Medical University WanFang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ming I Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

WanFang Medical Center at Taipei Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, Taiwan

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Taiwan

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Ming I Hsu, MD

Role: primary

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 24534286 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Hsu2013-TMU-JIRB 201302002

Identifier Type: -

Identifier Source: org_study_id