Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

November 5, 2013 updated by: Ming-I Hsu, Taipei Medical University WanFang Hospital

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

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.

Study Overview

Status

Completed

Conditions

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).

Study Type

Observational

Enrollment (Actual)

649

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Taipei, Taiwan, 116
        • WanFang Medical Center at Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

13 years to 48 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

A retrospective review of the medical records of women who visited the Reproductive Endocrinology Clinic was carried out at the Wan Fang Medical Center at Taipei Medical University from 2009 and up to 2012. A total of 160 Taiwanese women with hyperandrogenism (HA) and 165 women without hyperandrogenism (non-HA) were included in the study.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Controls
patients who have all androgens (TT, A4, FAI, and DHEA-S) lower than their cut-off values
Total Testosterone >= 2.39
Patients who have only total testosterone higher than its cut-off value; (TT) >=2.39
Androstenedione >= 2.99
Patients who have only androstenedione higher than its cut-off value; (A4) >=2.99
Free Androgen Index >= 6.53
Patients who have only free androgen index higher than its cut-off value; (FAI) >=6.53
DHEAs >= 181.55
Patients who have only dehyroepiandrosterone sulfate higher than its cut-off value; (DHEA-S)>=181.55

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women
Time Frame: 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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University WanFang Hospital

Investigators

  • Principal Investigator: Ming I Hsu, MD, WanFang Medical Center at Taipei Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

April 5, 2013

First Submitted That Met QC Criteria

September 11, 2013

First Posted (Estimate)

September 12, 2013

Study Record Updates

Last Update Posted (Estimate)

November 6, 2013

Last Update Submitted That Met QC Criteria

November 5, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • WFH-TMU-PCOS-201207025

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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