Malay Women With PCOS and Their Association With Metabolic Syndrome

NCT ID: NCT03414957

Last Updated: 2020-01-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 210 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-10-31

Brief Summary

The abnormalities that characterize the Metabolic Syndrome (MetS) confer an increased risk of cardiovascular and other diseases. Women with Polycystic Ovary Syndrome (PCOS), the commonest endocrine disease among women of childbearing age, have an increased risk of developing MetS.

2) The prevalence of MetS in PCOS patients varies among different ethnic groups. Malaysia is a unique country with a multiethnic population. The 3 largest ethnic groups are the Malays, Chinese and Indians. Previous studies in India and China have been able to determine the incidence of PCOS amongst those ethnic groups, but as yet, there is no published data on the prevalence of this disorder amongst women of Malay ethnicity. In this study, I intend to discover the prevalence of MetS amongst Malay women with established PCOS.

Detailed Description

Metabolic syndrome (MetS) is a well-known collection of interrelated metabolic conditions that identify patients at increased risk of developing cardiovascular disease. These conditions include diabetes mellitus (DM), high blood pressure, obesity and dyslipidaemia.1 Though the exact pathogenesis of MetS still remains elusive, central obesity and insulin resistance are generally acknowledged as important causative factors. The most recent

International Diabetes Federation (IDF) consensus has developed a definition emphasizing the importance of central obesity with modifications according to ethnic groups.2 Polycystic Ovarian Syndrome (PCOS) is the commonest endocrine disorder in women of reproductive age.3 Around 6-7% of women in the reproductive age group are estimated afflicted with this disorder, which accounts for more than 75% of anovulatory infertility.4 PCOS is characterized by both reproductive and metabolic dysfunctions such as hyperandrogenism, infertility, and increased long term risks of type 2 diabetes, dyslipidaemia, hypertension, visceral obesity, and endometrial cancer. Women with PCOS have been noted to have high incidences of age group-specific prevalence of type 2 DM, myocardial infarct and angina (Mani H 2012). The criteria developed in Rotterdam in 2003 remains the most widely accepted for the diagnosis of PCOS.7 For a diagnosis of PCOS to be made, a minimum of 2 features from oligo/anovulation, hyperandrogenaemia and ultrasound demonstration of polycystic ovaries need to be present. Other causes of polycystic ovaries such as adrenal hyperplasia, androgen-secreting tumours and Cushing's syndrome have to be excluded, of course.

Insulin resistance, which is an established feature of PCOS, leads to compensatory hyperinsulinaemia and affects both the theca and granulosa of the ovary (Franks S 1999, Franks S 2008). Insulin increases serum androgen levels through its function as an ovarian growth hormone (leading to increased theca cell androgen synthesis) and its action on adrenal steroidogenesis (Barbieri RL 1986, Moghetti P 1996). The consequent hyperandrogenaemia interferes with normal folliculogenesis and ovulation. The concerted effects of the elevated serum insulin and androgen levels account for many of the features of PCOS and the metabolic syndrome (Barber TM 2012). It is apparent that insulin resistance, androgen excess, anovulation, metabolic abnormalities and PCOS are all related to each other and form a tangled web. PCOS is now viewed as a clinical phenotype of MetS.5,6

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Conditions

Polycystic Ovary Syndrome (PCOS); Metabolic Syndrome

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Malay PCOS women

Malay women underwent clinical assessment, followed by pelvic ultrasound scan, biochemical and hormonal blood tests. Using the Rotterdam criteria for the diagnosis of PCOS, Malay women who fulfilled these criteria were inducted into this group. These women were then identified whether they had Metabolic Syndrome or not based on the WHO criteria

Hormonal and biochemical blood tests and ultrasound scanning

Intervention Type: DIAGNOSTIC_TEST

Subjects undergo clinical assessment, blood tests and a pelvic ultrasound scan, to determine if they have either PCOS or Metabolic Syndrome or both

Malay women without PCOS

Malay women underwent clinical assessment, followed by pelvic ultrasound scan, biochemical and hormonal blood tests. Using the Rotterdam criteria for the diagnosis of PCOS, Malay women who did not fulfill these criteria were inducted into this group. These women were then identified whether they had Metabolic Syndrome or not based on the WHO criteria.

Hormonal and biochemical blood tests and ultrasound scanning

Intervention Type: DIAGNOSTIC_TEST

Subjects undergo clinical assessment, blood tests and a pelvic ultrasound scan, to determine if they have either PCOS or Metabolic Syndrome or both

Interventions

Hormonal and biochemical blood tests and ultrasound scanning

Subjects undergo clinical assessment, blood tests and a pelvic ultrasound scan, to determine if they have either PCOS or Metabolic Syndrome or both

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Malay women aged 20-40 years of age
• clinically healthy and euthyroid (clinically and biochemically) and not on any medication.

Exclusion Criteria

• women on any hormonal medications

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cyberjaya University College of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Hanif Khan

Role: PRINCIPAL_INVESTIGATOR

Associate Professor

Other Identifiers

CUCMS/RA/CGS/9-5

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CRG/05/04/2011

Identifier Type: -

Identifier Source: org_study_id