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

Insulin Resistance, Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01989039
• Other study ID #: Hsu2013-TMU-JIRB201307021
• Status: Recruiting
• Phase: N/A
• First received: October 21, 2013
• Last updated: November 19, 2013
• Start date: August 2013
• Est. completion date: July 2014

Study information

• Verified date: November 2013
• Source: Taipei Medical University WanFang Hospital
• Contact: Ming I Hsu, MD
• Phone: 886-2-2930-7930
• Email: hsumingi[@]yahoo.com.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Observational

Clinical Trial Summary

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、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、inflammatory and cardiovascular markers between PCOS and non-PCOS among obese and non-obese women.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 800
• Est. completion date: July 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 48 Years

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Insulin Resistance
• Insulin Resistance,
• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome,

Locations

Country	Name	City	State
Taiwan	WanFang Medical Center at Taipei Medical University	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University WanFang Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Studying the insulin resistance, inflammatory and cardiovascular markers in polycystic ovary syndrome among obese and non-obese women.		A retrospective study in 800 Taiwanese women medical records reviewed from 2009 to 2012, up to 4 years in Wan Fang Hospital.	No