Trials / Completed
CompletedNCT01940666
Presentations of Hyperandrogenic Phenotypes in Taiwanese Women
Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 649 (actual)
- Sponsor
- Taipei Medical University WanFang Hospital · Academic / Other
- Sex
- Female
- Age
- 13 Years – 48 Years
- Healthy volunteers
- Not accepted
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, DURATION:A 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. PARTICIPANTS/MATERIALS, 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).
Conditions
- Hyperandrogenism,
- Polycystic Ovary Syndrome,
- Metabolic Syndrome,
- Insulin Resistance,
- Cardiovascular Disease.
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2013-03-01
- Completion
- 2013-07-01
- First posted
- 2013-09-12
- Last updated
- 2013-11-06
Locations
1 site across 1 country: Taiwan
Source: ClinicalTrials.gov record NCT01940666. Inclusion in this directory is not an endorsement.