Database of patients with polycystic ovary syndrome and healthy women
| ISRCTN | ISRCTN70196169 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70196169 |
| Secondary identifying numbers | R1042 10/H0906/17 |
- Submission date
- 09/05/2012
- Registration date
- 22/05/2012
- Last edited
- 13/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Plain English summary of protocol
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
Contact information
Scientific
Michael White Diabetes Centre
Hull Royal Infirmary
220-236 Anlaby Road
Hull
HU3 2RW
United Kingdom
Study information
| Study design | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Other |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Genetic database of patients with polycystic ovary syndrome and healthy women: a cohort study |
| Study objectives | 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(s) | Ethics approval granted by Newcastle 1 REC, UK, 10/01/2012, ref: 10/H0906/17 |
| Health condition(s) or problem(s) studied | 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 |
| 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 study start date | 01/10/2011 |
| Completion date | 01/01/2013 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 500 |
| Key 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 |
| Key exclusion criteria | 1. Non-classical 21-hydroxylase deficiency 2. Hyperprolactinaemia 3. Cushing's disease 4. Androgen-secreting tumours |
| Date of first enrolment | 01/10/2011 |
| Date of final enrolment | 01/01/2013 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
HU3 2RW
United Kingdom
Sponsor information
Hospital/treatment centre
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
England
United Kingdom
"ROR" |
https://ror.org/01b11x021 |
|---|
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 19/11/2015 | Yes | No | |
| Results article | results | 01/12/2017 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No |
Editorial Notes
13/02/2018: Publication reference added.
26/11/2015: no publications found on PubMed.
