Status:
UNKNOWN
Dissecting the IMpact of 11-OXygenated and Classic Androgens on Skeletal Muscle Insulin Sensitivity (DIMOXIS)
Lead Sponsor:
Royal College of Surgeons, Ireland
Collaborating Sponsors:
University of Oxford
University of Birmingham
Conditions:
Polycystic Ovary Syndrome
Insulin Resistance
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Androgen excess is the cardinal biochemical feature of polycystic ovary syndrome (PCOS). Serum testosterone correlates with insulin resistance in PCOS, however, there is an urgent need to improve our ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT05263557
Start Date
August 19 2022
End Date
December 1 2024
Last Update
July 25 2023
Active Locations (1)
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1
Beaumont Hospital
Dublin, Ireland