IR, Inflammatory and Cardiovascular Markers in PCOS Among Obese and Non-obese Women

NCT ID: NCT01989039

Last Updated: 2013-11-20

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

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-07-31

Brief Summary

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

FPCOS is associated with an adverse cardiometabolic profile, consisting of increased total or central adiposity, increased insulin resistance and abnormal glucose metabolism. Low-grade chronic inflammation predicts cardiovascular outcomes and is observed in women with PCOS. However, obesity is also associated with increased inflammatory markers. Obesity is per se associated with increased adipose expression and plasma levels of leptin, lower expression of adiponectin, and elevated inflammatory markers. To study the insulin resistance态inflammatory markers and cardiovascular risk in women with PCOS, body weight status should be considered. Investigator therefore conduct this retrospective study to evaluate the insulin resistance态inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.

Detailed Description

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

Conditions

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

Polycystic Ovary Syndrome, Insulin Resistance,

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 insulin resistance, cardiovascular and inflammatory markers.

Exclusion Criteria

* women who had been diagnosed with malignant tumor, Asherman's syndrome, Mullerian agenesis, ovarian failure, hyperprolactinemia, 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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

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

Taipei Medical University WanFang Hospital

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

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Ming I Hsu, MD

Role: CONTACT

Phone: 886-2-2930-7930

Email: [email protected]

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.

Shen SH, Shen SY, Liou TH, Hsu MI, Chang YC, Cheng CY, Hsu CS, Tzeng CR. Obesity and inflammatory biomarkers in women with polycystic ovary syndrome. Eur J Obstet Gynecol Reprod Biol. 2015 Sep;192:66-71. doi: 10.1016/j.ejogrb.2015.06.022. Epub 2015 Jul 2.

Reference Type DERIVED
PMID: 26177495 (View on PubMed)

Chen CI, Hsu MI, Lin SH, Chang YC, Hsu CS, Tzeng CR. Adiponectin and leptin in overweight/obese and lean women with polycystic ovary syndrome. Gynecol Endocrinol. 2015 Apr;31(4):264-8. doi: 10.3109/09513590.2014.984676. Epub 2014 Nov 25.

Reference Type DERIVED
PMID: 25423261 (View on PubMed)

Other Identifiers

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

Hsu2013-TMU-JIRB201307021

Identifier Type: -

Identifier Source: org_study_id