NCT03911297Recruiting
DAISy-PCOS Phenome Study - Dissecting Androgen Excess and Metabolic Dysfunction in Polycystic Ovary Syndrome
Dissecting Androgen Excess and Metabolic Dysfunction for an Integrated Systems Approach to Polycystic Ovary Syndrome Through the Assessment of Detailed Phenome and Metabolome Data
Source: ClinicalTrials.gov · Last updated 5 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Polycystic ovary syndrome (PCOS) affects 10% of all women and usually presents with irregular menstrual periods and difficulties conceiving. However, PCOS is also a lifelong metabolic disorder and affected women have an increased risk of type 2 diabetes, high blood pressure, and heart disease. Increased blood levels of male hormones, also termed androgens, are found in most PCOS patients. Androgen excess appears to impair the ability of the body to respond to the sugar-regulating hormone insulin (=insulin resistance). The investigator has found that fat tissue of PCOS patients overproduces androgens and that this can result in a build-up of toxic fat, which increases insulin resistance and could cause liver damage. In a large cohort of women registered in a GP database, the study team have found that androgen excess increases the risk of fatty liver disease. The aim is to identify those women with PCOS who are at the highest risk of developing metabolic disease, which would allow for early detection and potentially prevention of type 2 diabetes, high blood pressure, fatty liver and cardiovascular disease. The investigator will assess clinical presentation, androgen production and metabolic function in women with PCOS to use similarities and differences in these parameters for the identification of subsets (=clusters) of women who are at the highest risk of metabolic disease. The investigator will do this by using a standardised set of questions to scope PCOS-related signs and symptoms and the patient's medical history and measure body composition and blood pressure. This standardised recording of a patient's clinical presentation (=clinical phenotype) is called Phenome analysis. The investigator will collect blood and urine samples for the systematic measurement of steroid hormones including a very detailed androgen profile (=steroid metabolome analysis) and of thousands of substances produced by human metabolism (=global metabolome analysis). Phenome and metabolome data will then undergo integrated computational analysis for the detection of clusters predictive of metabolic risk.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 1000 (estimated)
- First submitted
- 8 Apr 2019
- Start date
- 14 Aug 2019
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Imperial College London
- NCT number
- NCT03911297
What you commit to
- Study type: Observational
- Planned participants: 1000
- From 14 Aug 2019 to the primary completion date, 31 Dec 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Current intake of drugs known to impact upon steroid or metabolic function or intake of such drugs during the six months preceding the planned recruitment
- Use of contraceptive implants in the twelve months preceding the planned recruitment
Other illness
- Any other significant disease or disorder that, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study.
Lab values
- History of significant renal (eGFR\<30) or hepatic impairment (AST or ALT \>two-fold above ULN; pre-existing bilirubinaemia \>1.2 ULN)
Other
- Pregnancy or breastfeeding at the time of planned recruitment
- Participants who have participated in another research study involving an investigational medicinal product in the 12 weeks preceding the planned recruitment
- Glucocorticoid use via any route within the last six months
- Use of oral or transdermal hormonal contraception in the three months preceding the planned recruitment
Who the study is looking for
- Women with a suspected diagnosis of polycystic ovary syndrome
- Age range 18-70 years
- Ability to provide informed consent
Age in the registry: 18 years to 70 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wellcome Trust Clinical Research Facility Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.