Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

Cardiovascular Disease. Clinical Trial

Official title:

Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01940666
• Other study ID #: WFH-TMU-PCOS-201207025
• Status: Completed
• Phase: N/A
• First received: April 5, 2013
• Last updated: November 5, 2013
• Start date: September 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: Taipei Medical University WanFang Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 649
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 13 Years to 48 Years

Eligibility

Inclusion Criteria:

• Hyperandrogenic women who were classified into four groups:

• Total testosterone (TT),

• Androstenedione (A4),

• Free androgen index (FAI),

• and Dehydroepiandrosterone sulphate(DHEA-S).

• According to abnormally elevated androgen measures each above its cut-off value, and non hyperandrogenic women (who had all androgens below their cut-off values)

Exclusion Criteria:

• None of the women studied had

• Hypogonadotropic hypogondism,

• Hyperprolactinemia,

• Congenital adrenal hyperplasia,

• Premature ovarian failure,

• Androgen-secreting tumors,

• Cushing's syndrome,

• or any other endocrine or systemic disease that may affect the reproductive function,

• or any disorders of the uterus (e.g. Asherman's syndrome and Mullerian genesis) and chromosomal anomalies (e.g. Turner's syndrome).

• In addition, we excluded females who had

• Experienced menarche less than three years preceding the study start,

• or who had day 3 FSH > 15 mIU/ml, as well as women with insufficient clinical/biochemical records,

• and women with ovarian cysts or tumors in an ultrasonographic examination.

Related Conditions & MeSH terms

• Cardiovascular Disease.
• Cardiovascular Diseases
• Hyperandrogenism
• Hyperandrogenism,
• Insulin Resistance
• Insulin Resistance,
• Metabolic Syndrome X
• Metabolic Syndrome,
• Polycystic Ovary Syndrome
• Polycystic Ovary Syndrome,
• Syndrome

Locations

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

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	Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women	Androgens (Total Testosterone (TT) (nmol/L), androstenedione (A4)(ng/ml), free androgen index (FAI), and dehydroepiandrosterone sulfate (DHEA-S) (µg/dl ); anthroponmetric components (body mass index (BMI)(Kg/m2) , waist (cm), Waist-to-hip ratio (W/H)); average menstrual interval, antimullerian hormone(AMH)(ng/ml) adiponectin (ng/nl), leptin(ng/ml), adiponectin/leptin (A/L) ratio, and insulin resistance markers( fasting insulin (µIU/ml), glucose-to-insulin ratio (GIR), Homeostasis model assessment insulin resistance (HOMA-IR) Index, Lipid Accumulation Product Index (LAP Index)).	A retrospective study in 160 Taiwanese women with HA and 165 women without HA, with medical records reviewed from January 1, 2009, through July 21, 2012 (up to 3.5 years)