Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:40 PM
Ignite Modification Date:
2025-12-24 @ 6:40 PM
NCT ID:
NCT03414957
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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Study:
NCT03414957
Study Brief:
Protocol Section:
NCT03414957