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Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

NCT ID: NCT01940666

Last Updated: 2013-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

649 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-07-31

Brief Summary

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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

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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

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Hyperandrogenism, Polycystic Ovary Syndrome, Metabolic Syndrome, Insulin Resistance, Cardiovascular Disease.

Keywords

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Hyperandrogenism/ FAI/ Metabolic syndrome/ Adipocytokines/ Insulin resistance.

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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Controls

patients who have all androgens (TT, A4, FAI, and DHEA-S) lower than their cut-off values

No interventions assigned to this group

Total Testosterone >= 2.39

Patients who have only total testosterone higher than its cut-off value; (TT) \>=2.39

No interventions assigned to this group

Androstenedione >= 2.99

Patients who have only androstenedione higher than its cut-off value; (A4) \>=2.99

No interventions assigned to this group

Free Androgen Index >= 6.53

Patients who have only free androgen index higher than its cut-off value; (FAI) \>=6.53

No interventions assigned to this group

DHEAs >= 181.55

Patients who have only dehyroepiandrosterone sulfate higher than its cut-off value; (DHEA-S)\>=181.55

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

13 Years

Maximum Eligible Age

48 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University WanFang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Ming-I Hsu

Taipei Medical University WanFang Hospital

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ming I Hsu, MD

Role: PRINCIPAL_INVESTIGATOR

WanFang Medical Center at Taipei Medical University

Locations

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WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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WFH-TMU-PCOS-201207025

Identifier Type: -

Identifier Source: org_study_id