Plain English Summary
Background and study aims
Polycystic ovary syndrome (PCOS) is a common hormone problem in young women and, as a result of it, they can experience irregular periods, reduced fertility, acne and increased body hair. Research suggests that they could have a higher risk of diabetes, because of their increased weight and also because they seem to have higher insulin levels. There is also the concern that there is an increased risk of cardiovascular disease (hypertension, heart attack, and stroke). Research shows that an increasing number of illnesses have a genetic element. Diabetes, asthma, certain heart conditions are now thought to have a genetic component. Early research suggests that PCOS might have a genetic component as well. We are comparing patients with polycystic ovary syndrome to women without polycystic ovary syndrome who are premenopausal.
Who can participate?
Women with polycystic ovary syndrome as well as healthy women are invited to participate.
What does the study involve?
The study includes two visits to Diabetes research centre, Hull Royal Infirmary. You will be requested to fill questionnaires as well as blood (approx 7 tablespoons of blood sample will be taken), urine, saliva and sebum will be collected. We will also arrange for ultrasound examination as well as tests to check the function of blood vessels.
What are the possible benefits and risks of participating?
For most people needle punctures for blood draws do not cause any serious problems. Some people feel faint, and there may be some pain and bruising (or, very rarely, infection) where the needle goes in. Please, let us know if you have had a problem in the past. The study will not bring direct benefits to you, but the information we get from this study may help to reduce the risks of heart attacks and stroke in patients with polycystic ovary syndrome. Your contribution and participation in this study will advance the knowledge on the causes of PCOS and related conditions including obesity and type 2 diabetes which could be helpful for the development of treatments or preventive measures.
Where is the study run from?
The study is conducted in Clinical Research Unit, Michael White Diabetes Centre, Hull Royal Infirmary, Hull, UK
When is study starting and how long is it expected to run for?
The study started in 2011 and we plan to recruit by 2013.
Who is funding the study?
This study is supported by a grant from Hull York Medical School
Who is the main contact?
Dr Thozhukat Sathyapalan
thozhukat.sathyapalan@hyms.ac.uk
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
R1042 10/H0906/17
Study information
Scientific title
Genetic database of patients with polycystic ovary syndrome and healthy women: a cohort study
Acronym
Study hypothesis
This is a database for polycystic ovary syndrome (PCOS) and control women for genomic studies and elucidating biological pathways underlying the development of the PCOS phenotype and to identify the genetic factors associated with the increased cardiovascular risk that these patients have.
Ethics approval
Ethics approval granted by Newcastle 1 REC, UK, 10/01/2012, ref: 10/H0906/17
Study design
Observational cohort study
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Other
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Polycystic ovay syndrome
Intervention
All subjects will be asked to arrive fasting in the morning. Informed consent will be taken. Blood, saliva, sebum and urine samples will be collected during the follicular phase of menstrual cycle if the cycles are regular. All subjects will be asked to fill out a questionnaire. Subjects will then undergo further history, physical exam and laboratory exams. All the samples and data including history as well as questionnaires will be stored securely linked anonymised. Transvaginal / transabdominal ultrasound and endo PAT as well as blood samples will be done in a seperate visit. Consent will be taken to contact back the patient if needed in the future for follow up.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Cardiovascular risk will be assessed by lipid profile, high-sensitivity C-reactive protein (hsCRP), 75g oral glucose tolerance test, HOMA and endo PAT
Secondary outcome measures
1. Genetic polymorphism: DNA samples will be extracted and studied for genetic polymorphisms
2. Hormonal parameters including free androgen index, Dehydroepiandrosterone sulfate (DHEAS), androstenedione and 17OH progesterone will be measured
3. Quality of life will be assessed using questionnaires including PCOS QoL questionnaire
Overall trial start date
01/10/2011
Overall trial end date
01/01/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. PCOS subjects as per Rotterdam criteria
2. Age 18 to 40 years
Inclusion criteria - controls
1. Aged 18 to 40 years
2. Regular menstrual cycles 21 to 35 days
3. No clinical or biochemical evidence of hyperandrogenemia
4. Normal thyroid-stimulating hormone (TSH) and prolactin
5. No first degree relatives having polycystic ovary syndrome
Participant type
Mixed
Age group
Adult
Gender
Female
Target number of participants
500
Participant exclusion criteria
1. Non-classical 21-hydroxylase deficiency
2. Hyperprolactinaemia
3. Cushing's disease
4. Androgen-secreting tumours
Recruitment start date
01/10/2011
Recruitment end date
01/01/2013
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Michael White Diabetes Centre
Hull
HU3 2RW
United Kingdom
Sponsor information
Organisation
Hull and East Yorkshire Hospitals NHS Trust (UK)
Sponsor details
Mr James Illingworth
R&D Manager
Research & Development Department
Hull & East Yorkshire Hospitals NHS Trust
2nd Floor Daisy Building
Castle Hill Hospital
Cottingham
East Yorkshire
Hull
HU16 5JQ
United Kingdom
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
University/education
Funder name
Hull York Medical School (HYMS) (UK) - Pump Priming Grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2015 results in https://www.ncbi.nlm.nih.gov/pubmed/26582398
2017 results in https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5472559/