Viewing Study NCT01940666



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Study NCT ID: NCT01940666
Status: COMPLETED
Last Update Posted: 2013-11-06
First Post: 2013-04-05

Brief Title: Presentations of Hyperandrogenic Phenotypes in Taiwanese Women
Sponsor: Taipei Medical University WanFang Hospital
Organization: Taipei Medical University WanFang Hospital

Study Overview

Official Title: Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women
Status: COMPLETED
Status Verified Date: 2013-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: STUDY QUESTION Which of the four abnormally elevated androgen groups total testosterone TT androstenedione A4 free androgen index FAI or dehydroepiandrosterone-sulfate DHEA-S present with an unfavorable metabolic and hormonal profile appear to be more insulin-resistant and pose additional cardiovascular risk SUMMARY ANSWER Subjects with excess free androgen index tend to be obese and face the highest metabolic syndrome risk adipocytokine alterations insulin resistance IR and cardiovascular risk The excess TT group presents with a marginal IR risk while the excess A4 group has the highest antimüllerian hormone AMH and may counterbalance obesity this group and the excess DHEA-S group have a favorable association with IR
Detailed Description: STUDY DESIGN SIZE DURATIONA retrospective study in 160 Taiwanese women with HA and 165 women without HA with medical records reviewed from 2009 up to 2012 The hyperandrogenic women were classified into four groups TT A4 FAI and DHEA-S according to independent abnormally elevated androgen measures each above its cut-off value and the groups were compared with each other and with controls

PARTICIPANTSMATERIALS SETTING METHODS This study was performed in the Reproductive Endocrinology Clinic at Wan Fang Medical Center in Taipei Taiwan Anthropometric metabolic endocrine and IR components as well as lipid accumulation product LAP index were compared between the groups IR was assessed with the following markers fasting glucose and insulin levels oral glucose tolerance test glucose-to-insulin ratio and homeostasis model assessment of IR index HOMA-IR

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None