Status:
UNKNOWN
Impact of 11-oxygenated Androgens on Metabolic Dysfunction of Women With Polycystic Ovary Syndrome
Lead Sponsor:
University of Birmingham
Conditions:
Polycystic Ovary Syndrome
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
Polycystic ovary syndrome (PCOS) affects 10% of all women and usually presents with irregular menstrual periods and difficulties conceiving. It is also a lifelong metabolic disorder and affected women...
Detailed Description
In part A of the study, women with PCOS and obesity, identified from the previously established DAISy-PCOS cohort, and age- and BMI-matched healthy volunteers identified by advertisements, will be inv...
Eligibility Criteria
Inclusion
- Part A
- 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
- 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
Key Trial Info
Start Date :
October 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05246865
Start Date
October 10 2021
End Date
May 30 2025
Last Update
November 2 2022
Active Locations (1)
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1
Institute of Metabolism and Systems Research
Birmingham, West Midlands, United Kingdom, B15 2TT