Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier:
NCT01940666
First received: April 5, 2013
Last updated: November 5, 2013
Last verified: November 2013
  Purpose

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.


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

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: Clinical and Biochemical Presentations of Distinctive Types of Biochemical Hyperandrogenism in Premenopausal Taiwanese Women

Resource links provided by NLM:


Further study details as provided by Taipei Medical University WanFang Hospital:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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)).


Enrollment: 649
Study Start Date: September 2012
Study Completion Date: July 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

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).

  Eligibility

Ages Eligible for Study:   13 Years to 48 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01940666

Locations
Taiwan
WanFang Medical Center at Taipei Medical University
Taipei, Taiwan, 116
Sponsors and Collaborators
Taipei Medical University WanFang Hospital
Investigators
Principal Investigator: Ming I Hsu, MD WanFang Medical Center at Taipei Medical University
  More Information

No publications provided

Responsible Party: Ming-I Hsu, Taipei Medical University WanFang Hospital
ClinicalTrials.gov Identifier: NCT01940666     History of Changes
Other Study ID Numbers: WFH-TMU-PCOS-201207025
Study First Received: April 5, 2013
Last Updated: November 5, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Taipei Medical University WanFang Hospital:
Hyperandrogenism/
FAI/
Metabolic syndrome/
Adipocytokines/
Insulin resistance.

Additional relevant MeSH terms:
Cardiovascular Diseases
Insulin Resistance
Polycystic Ovary Syndrome
Hyperandrogenism
Metabolic Syndrome X
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Testosterone
Testosterone enanthate
Testosterone undecanoate
Testosterone 17 beta-cypionate
Methyltestosterone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 24, 2014