Polycystic Ovary Syndrome (PCOS)MPMSSNCT03414957
Malay Women With PCOS and Their Association With Metabolic Syndrome
An observational study of Polycystic Ovary Syndrome (PCOS) and Metabolic Syndrome, run by Cyberjaya University College of Medical Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Polycystic Ovary Syndrome (PCOS), Metabolic Syndrome
- What is being tested?
- Hormonal and biochemical blood tests and ultrasound scanning
- How many people
- 210 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to Oct 2017
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- Malay women aged 20-40 years of age
- clinically healthy and euthyroid (clinically and biochemically) and not on any medication.
Who cannot join
- women on any hormonal medications
About this study
Official title: Prevalence of Metabolic Syndrome Amongst Malay Women With PCOS
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.
- 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.
Read the 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
.
- Being tested
- Hormonal and biochemical blood tests and ultrasound scanning
- Keywords
- Malay women, PCOS, Metabolic Syndrome, Rotterdam criteria
- Medical subject headings
- Polycystic Ovary Syndrome, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hormonal and biochemical blood tests and ultrasound scanningDiagnostic test
Subjects undergo clinical assessment, blood tests and a pelvic ultrasound scan, to determine if they have either PCOS or Metabolic Syndrome or both
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Diagnostic Test: Hormonal and biochemical blood tests and ultrasound scanning |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study startNov 2012
- Primary completionNov 2016
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Polycystic Ovary Syndrome (PCOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 210 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Cyberjaya University College of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hanif Khan, Principal investigator, Associate Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414957
- Sponsor's protocol ID
- CRG/05/04/2011
- Other IDs
- CUCMS/RA/CGS/9-5
- Acronym
- MPMSS
- Status last verified
- Jan 2020
- First submitted
- 23 Jan 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All participant demographics and results as well as calculations
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Metabolic Syndrome Amongst Malay Women With PCOS
- ClinicalTrials.gov ID
- NCT03414957
- Acronym / sponsor ID
- MPMSS / CRG/05/04/2011
- Keywords
- Malay women, PCOS, Metabolic Syndrome, Rotterdam criteria
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 210 participants (actual)
- Lead sponsor
- Cyberjaya University College of Medical SciencesUniversity, hospital or other
- Study start
- Nov 2012 (actual)
- Primary completion
- Nov 2016 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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
.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Malay PCOS women | – | Diagnostic Test: Hormonal and biochemical blood tests and ultrasound scanningMalay 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 |
| Malay women without PCOS | – | Diagnostic Test: Hormonal and biochemical blood tests and ultrasound scanningMalay 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (2 listed)
- Malay women aged 20-40 years of age
- clinically healthy and euthyroid (clinically and biochemically) and not on any medication.
Key exclusion criteria (1 listed)
- women on any hormonal medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hormonal and biochemical blood tests and ultrasound scanningSubjects undergo clinical assessment, blood tests and a pelvic ultrasound scan, to determine if they have either PCOS or Metabolic Syndrome or both | Diagnostic test | Malay PCOS women, Malay women without PCOS |
Primary outcome
Prevalence of Metabolic Syndrome Amongst Malay Women with PCOS
Time frame: 6 months
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Yes. All participant demographics and results as well as calculations
Related trials for Polycystic Ovary Syndrome (PCOS)
Recruiting
Efficacy of Ovarian Drilling Via vNOTES Laparoscopy in Patients With PCOS
PCOS (Polycystic Ovary Syndrome)
RecruitingPhase 1
Efficacy of Injectable Vitamin D Supplementation in Females With Polycystic Ovary Syndrome
Anovulatory Infertility
RecruitingObservational study
The Value of LC-MS/MS Detection of Androgen Profiles in the Diagnosis of PCOS: A Prospective, Multicenter Real-world Study
Polycystic Ovary Syndrome (PCOS)
Recruiting
The Effects of the Mediterranean Diet and Synbiotics in Polycystic Ovary Syndrome
PCOS (Polycystic Ovary Syndrome)
Recruiting
Brown Adipose Tissue Modulation in Polycystic Ovary Syndrome Using Infrared Thermography
Polycystic Ovary Syndrome (PCOS)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hanif Khan principal investigator
Associate Professor
Questions about this trial
What is this clinical trial studying?
An observational study of Polycystic Ovary Syndrome (PCOS) and Metabolic Syndrome, run by Cyberjaya University College of Medical Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Metabolic Syndrome Amongst Malay Women with PCOS (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2020.