Effects of 11-oxygenated androgens on metabolic issues in women with PCOS
The Role of 11-oxygenated Androgens in Androgen Excess and Metabolic Dysfunction of Women With Polycystic Ovary Syndrome
NA · University of Birmingham · NCT05246865
This study is testing how certain hormones affect weight and blood sugar issues in women with PCOS and obesity to see if they can help improve their health.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | University of Birmingham (other) |
| Locations | 1 site (Birmingham, West Midlands) |
| Trial ID | NCT05246865 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of 11-oxygenated androgens on metabolic dysfunction in women diagnosed with polycystic ovary syndrome (PCOS) and obesity. Participants will undergo a series of metabolic assessments, including an androgen-precursor challenge and blood flow measurements in abdominal adipose tissue. The study aims to better understand how these androgens affect insulin resistance and other metabolic parameters in this population. The research is conducted at the National Institute of Health Research-Wellcome Trust Clinical Research Facility in Birmingham.
Who should consider this trial
Good fit: Ideal candidates are women aged 18-40 with a BMI between 30-40 kg/m2 who have been diagnosed with PCOS.
Not a fit: Patients outside the specified age range, BMI criteria, or without a diagnosis of PCOS may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for metabolic dysfunction in women with PCOS.
How similar studies have performed: While studies on androgens in PCOS exist, the specific focus on 11-oxygenated androgens represents a novel approach that has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Part A Inclusion Criteria: * BMI between 30-40 kg/m2 * Age range 18-40 years * Ability to provide informed consent For women participating in the PCOS group, the diagnosis of PCOS will be established during their recruitment to DAISy-PCOS study on the basis of the Rotterdam Consensus Criteria for the Diagnosis of PCOS, as recommended by the current international PCOS guidelines (at least 2 out of 3 criteria): * Androgen excess (clinical and/or biochemical evidence) * Chronic oligo-/anovulation (clinical and/or biochemical evidence) * Polycystic appearance of the ovaries on ultrasound (according to the most recent guidelines (10), taking into account the higher resolution capacity of modern ultrasound, the presence of ovarian PCOS morphology is defined as follows: 20 or more follicles of 2-9mm in diameter and/or an increased ovarian volume \>10 millilitre \[without a cyst or dominant follicle\] in either ovary) In addition, we will perform clinical and/or biochemical exclusion, as appropriate, of other conditions that could explain the above manifestation (e.g. congenital adrenal hyperplasia, Cushing's syndrome, Prolactinoma, adrenal and gonadal tumours) Exclusion Criteria: * Pregnancy or breastfeeding at the time of planned recruitment * History of significant renal (eGFR\<30) or hepatic impairment (aspartate aminotransferase or alanine transaminase \>two-fold above ULN; pre-existing bilirubinaemia \>1.2 ULN) * 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. * 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 * Current intake of drugs known to impact upon steroid synthesis or metabolism or on metabolic function or intake of such drugs during the six months preceding the planned recruitment * Use of oral or transdermal hormonal contraception in the three months preceding the planned recruitment * Use of contraceptive implants in the twelve months preceding the planned recruitment * Allergy or intolerance to any of the ingredients in the high fat meal, or any of the ingredients in the dehydroepiandrosterone and 11-ketoandrostenedione preparations. * Diabetes or impaired glucose metabolism Part B Inclusion criteria * Women undergoing elective, abdominal, non-cancer surgery * Age range 18-70 years * Ability to provide informed consent Exclusion criteria * Pregnancy or breastfeeding at the time of planned recruitment * Glucocorticoid use via any route within the last six months * Current intake of drugs known to impact upon steroid synthesis or metabolism or on metabolic function or intake of such drugs during the six months preceding the planned recruitment * Type 1 diabetes * Medical treatment of type 2 diabetes
Where this trial is running
Birmingham, West Midlands
- Institute of Metabolism and Systems Research — Birmingham, West Midlands, United Kingdom (RECRUITING)
Study contacts
- Principal investigator: Wiebke Arlt, Dsc — Director, Institute of Metabolism and Systems Research (IMSR)
- Study coordinator: Punith Kempegowda, MD MRCP
- Email: p.kempegowda@bham.ac.uk
- Phone: +441214147525
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Polycystic Ovary Syndrome