Examining the effects of androgens on insulin sensitivity in women with PCOS
Dissecting the IMpact of 11-OXygenated and Classic Androgens on Skeletal Muscle Insulin Sensitivity (DIMOXIS)
This study is testing how certain hormones affect insulin sensitivity in women with PCOS to see if they can help improve their metabolism and reduce the risk of type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | Female |
| Sponsor | Royal College of Surgeons, Ireland Academic / other |
| Locations | 1 site (Dublin 9) |
| Trial ID | NCT05263557 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of 11-oxygenated and classic androgens on insulin sensitivity in women diagnosed with polycystic ovary syndrome (PCOS). It aims to understand how these androgens, particularly 11-ketotestosterone, influence muscle glucose metabolism and the risk of developing type 2 diabetes. Participants will receive interventions with dehydroepiandrosterone (DHEA) and 11-ketoandrostenedione (11KA4) to assess changes in insulin sensitivity. The study seeks to fill the knowledge gap regarding the relationship between androgen excess and metabolic health in women with PCOS.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18-40 with a confirmed diagnosis of polycystic ovary syndrome and evidence of androgen excess.
Not a fit: Patients with a confirmed diagnosis of diabetes or those currently using weight loss medications or hormonal therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management strategies for insulin resistance in women with PCOS, potentially reducing the risk of type 2 diabetes.
How similar studies have performed: While the specific approach of examining 11-oxygenated androgens in this context is novel, previous studies have shown a correlation between androgen levels and insulin resistance in PCOS.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women with a confirmed diagnosis polycystic ovary syndrome with androgen excess on clinical or biochemical grounds * BMI 20.0-39.9kg/m2 * Age range 18-40 years * Ability to provide informed consent Exclusion Criteria: * A confirmed diagnosis of diabetes * Current or recent (\<3-months) use of weight loss medications * Current or recent use of oral contraceptive pill or hormone replacement therapy (within 3-months) * Blood haemoglobin \<12.0g/dL * History of alcoholism or a greater than recommended alcohol intake (recommendations \> 21 units on average per week for men and \> 14 units on average per week for women) * Haemorrhagic disorders or Treatment with anticoagulant agents * Any medical condition in the opinion of the investigator that might impact upon safety or validity of the results * Pregnancy or breastfeeding at the time of planned recruitment * A diagnosis of PCOS according to Rotterdam criteria where the patient does not have clinical or biochemical evidence of androgen excess * History of significant renal (eGFR\<30) or hepatic impairment (AST or ALT \>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. * 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
Where this trial is running
Dublin 9
- Beaumont Hospital — Dublin 9, Ireland (Recruiting)
Study contacts
- Principal investigator: Michael W Michael — RCSI Education & Research Centre, Beaumont Hospital, Beaumont Dublin 9 Ireland Ireland
- Study coordinator: Michael W O'Reilly
- Email: michaelworeilly@rcsi.ie
- Phone: 018093894
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.