Metabolic Cardiovascular SyndromeNCT01826357
Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age
An observational study of Metabolic Cardiovascular Syndrome, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 13 to 48 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Metabolic Cardiovascular Syndrome
- How many people
- 700 participants
- Where
- 1 siteTaiwan
- Study dates
- Mar 2013to Feb 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 48 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.
Who may be able to join
- Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
WanFang Medical Center at Taipei Medical University
Taipei, Taiwan, 116
Ming I Hsu, MD, 886-2-2930-7930 ext. 2508, hsumingi@yahoo.com.tw
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Cardiovascular Syndrome
- Keywords
- metabolic syndrome, cluster analysis, PCOS
- Medical subject headings
- Metabolic Syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Retrospectively reviewed the patients who visited Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2013 (estimated)
- Study startMar 2013
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic Cardiovascular SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ming-I Hsu, Taipei Medical University WanFang Hospital
- Investigators
- Ming I Hsu, MD, Principal investigator, WanFang Medical Center at Taipei Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01826357
- Sponsor's protocol ID
- Hsu2013-TMU-JIRB 201302002
- Status last verified
- Nov 2013
- First submitted
- 3 Apr 2013
- Last updated
- 6 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24534286
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Analysis of the Risk of Metabolic Syndrome in Women for Reproductive Age.
- ClinicalTrials.gov ID
- NCT01826357
- Acronym / sponsor ID
- Hsu2013-TMU-JIRB 201302002
- Conditions
- Metabolic Cardiovascular Syndrome
- Keywords
- metabolic syndrome, cluster analysis, PCOS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 8 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 13 to 48 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.
Key inclusion criteria (1 listed)
- Women had been fulfilled with whole anthropometric measurements, clinic and biochemical survey about cardiovascular study.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
metabolic syndrome
Time frame: Retrospectively reviewed the patients who visited Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2013.
- Derived from this study: PubMed 24534286Tzeng 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
WanFang Medical Center at Taipei Medical University
Taipei, Taiwan
Ming I Hsu, MD principal investigator
WanFang Medical Center at Taipei Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Cardiovascular Syndrome, run by Taipei Medical University WanFang Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
metabolic syndrome (time frame: Retrospectively reviewed the patients who visited Reproductive Endocrinology Clinic from Jan. 1, 2009 to Jun. 31, 2012.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01826357, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2013; AzTrials last refreshed its copy on 8 Nov 2026.