Malay Women With PCOS and Their Association With Metabolic Syndrome

NCT03414957 | Completed

• 2 other identifiers: CRG/05/04/2011CUCMS/RA/CGS/9-5
• Study Type: observational
• Target: 210
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Polycystic Ovary Syndrome (PCOS); Metabolic Syndrome

Keywords

Malay women, PCOS, Metabolic Syndrome, Rotterdam criteria

Outcome Measures

Primary Outcomes (1)

• Prevalence of Metabolic Syndrome Amongst Malay Women with PCOS

  To determine the prevalence of MetS amongst Malay women with PCOS and to compare this prevalence to that amongst Malay women without Polycystic Ovarian Syndrome.

  6 months

Study Arms (2)

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

Diagnostic Test: Hormonal and biochemical blood tests and ultrasound scanning

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.

Diagnostic Test: Hormonal and biochemical blood tests and ultrasound scanning

Interventions

Hormonal and biochemical blood tests and ultrasound scanning 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 PCOS women; Malay women without PCOS

Eligibility Criteria

• Age: 20 Years - 40 Years
• Gender Eligibility Details: Malay women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Malay women aged 20-40 years of age recruited from the clinical practices of the authors. 1. These will be subjects attending the Outpatient and the Gynaecology Clinics. 2. The subjects attending the Gynaecology Clinic will be those presenting with problems achieving pregnancy, excess body hair and/or menstrual disorders.

You may qualify if:

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

You may not qualify if:

• women on any hormonal medications

Sponsors & Collaborators

• Cyberjaya University College of Medical Sciences: lead

Biospecimen

Retention: SAMPLES WITH DNA

Serum used for biochemical and genetic tests

MeSH Terms

Conditions

Polycystic Ovary Syndrome; Metabolic Syndrome

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Ovarian Cysts; Cysts; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hanif Khan

  Associate Professor

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 23, 2018
• First Posted: January 30, 2018
• Study Start: November 1, 2012
• Primary Completion: November 1, 2016
• Study Completion: October 1, 2017
• Last Updated: January 23, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Once all the data and processing has been completed and will be available until further notice
• Access Criteria: Online open