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The Role of Insulin Resistance in PCOS

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ClinicalTrials.gov Identifier: NCT00173043
Recruitment Status : Unknown
Verified October 2004 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : September 15, 2005
Last Update Posted : November 24, 2005
Sponsor:
Information provided by:
National Taiwan University Hospital

Brief Summary:

Polycystic ovary syndrome (PCOS) phenotype can be structured into three components: anovulation, hyperandrogenism and the metabolic syndrome (of which hyperinsulinemia, secondary to insulin resistance, is the central abnormality)(1). It is the most common endocrinologic disease seen in Gynecologic clinic. The follicular excess in polycystic ovaries and the failure of selection of one dominant follicle contribute to the anovulation of PCOS. The infertile PCOS female usually suffered from difficult ovulation induction and high risk of ovarian hyperstimulation syndrome because of extensive stimulation.

PCOS is the main androgen disorder in women and has been suggested to be associated with a high risk of developing cardiovascular disease and type-2 diabetes. In many PCOS patients, overweight or central obesity is generally associated with increases in fasting insulin levels, insulin resistance, and glucose intolerance, and has been identified as a target for new therapeutic strategy, including early change in lifestyle.

Insulin resistance, defined as decreased insulin-mediated glucose utilization, is commonly (10-25%) found in the normal population. In women with PCOS, insulin resistance appears even more common (up to 50%), in both obese and non-obese women.Hyperinsulinemia appears to play a key pathogenic role in the ovarian androgen overproduction, because of the stimulatory effect of insulin on ovarian steroid production.


Condition or disease
Polycystic Ovary Syndrome Insulin Resistance Obesity

  Show Detailed Description

Study Type : Observational
Enrollment : 500 participants
Observational Model: Case Control
Observational Model: Natural History
Time Perspective: Longitudinal
Time Perspective: Prospective
Official Title: The Role of Insulin Resistance and Adiponectin in the Pathogenesis of Polycystic Ovary Syndrome
Study Start Date : October 2004
Study Completion Date : August 2005

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Ages Eligible for Study:   12 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Criteria for the definition of PCOS: (2 out of 3 in the following) Oligomenorrhea / chronic anovulation, defined as less than eight cycles of spontaneous menstrual period in one year.

Clinical and /or biochemical signs of hyperandrogenism Polycystic ovaries Exclusion of other aetiologies, such as congenital adrenal hyperplasia, androgen-secreting tumors, Cushing’s syndrome

Exclusion Criteria:

  • ever received hormone therapy in the past 6 months, having pregnancy in the past 6 months, having acute illness found in the past 3 months, or having systemic diseases including autoimmune disease, malignancy, hepatic, renal or CVS disease, and ever received chemotherapy or immunosuppressive agents.

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00173043


Contacts
Contact: Chen Mei-Jou, MD 886-2-23123456 ext 3950 metro@ha.mc.ntu.edu.tw

Locations
Taiwan
National Taiwan University Hospital Recruiting
Taipei, Taiwan, 100
Contact: Chen Mei-Jou, MD    886-2-23123456 ext 3950    metro@ha.mc.ntu.edu.tw   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
Principal Investigator: Yang Yu-Shih, M.D., PhD Department of Obstetrics and Gynecology, NTUH

ClinicalTrials.gov Identifier: NCT00173043     History of Changes
Other Study ID Numbers: 9361701208
NSC 94-2314-B-002-195-
First Posted: September 15, 2005    Key Record Dates
Last Update Posted: November 24, 2005
Last Verified: October 2004

Additional relevant MeSH terms:
Syndrome
Insulin Resistance
Polycystic Ovary Syndrome
Disease
Pathologic Processes
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases