Presentations of Hyperandrogenic Phenotypes in Taiwanese Women

NCT01940666 | Completed

• 1 other identifier: WFH-TMU-PCOS-201207025
• Study Type: observational
• Target: 649
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (5)

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

Eligibility Criteria

• Age: 13 Years - 48 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University WanFang Hospital: lead

Study Sites (1)

WanFang Medical Center at Taipei Medical University

Taipei, Taiwan, 116, Taiwan

Location

MeSH Terms

Conditions

Hyperandrogenism; Polycystic Ovary Syndrome; Metabolic Syndrome; Insulin Resistance; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Gonadal Disorders; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Genital Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Ming I Hsu, MD

  WanFang Medical Center at Taipei Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Taipei Medical University WanFang Hospital

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: September 12, 2013
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: November 6, 2013

Record last verified: 2013-11

Locations

TW (1)