At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Menopausal hormone therapy (drug)
- How long the study runs
- Study runs about 12 months (dates as stated)
- About the drug or intervention
- Menopausal hormone therapy — drug: Any brand, composition, route and dose of systemic menopausal hormone therapy containing oestrogen.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- Female
- Number of participants
- 10
- Started
- 2025-01
- Last checked
- 2025-01
Plain English Summary
What is this study?
- • Testing a new treatment for menopause
- • Phase1 - 10 participants
- • Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of chronic liver disease worldwide, currently affecting approximately 1-in-4 people globally
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with menopause
- • Female only
Where?
- • Oxford - Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM), Churchill Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common cause of chronic liver disease worldwide, currently affecting approximately 1-in-4 people globally. The prevalence is expected to rise further, driven at least partly by the epidemic of obesity and diabetes. MASLD is a condition of fat build-up in the liver that can progress to liver scarring which is associated with higher chances of death. Women are more than twice as likely to develop MASLD after menopause compared to before menopause, and previous research has shown that this may be caused by a lack of oestrogen. A lack of oestrogen is also believed to lead to harmful changes in adipose (body fat), which has an important role in the development of MASLD. Oestrogen contained in hormone replacement therapy (HRT) is an effective treatment for hot flushes and other problems in menopause. The popularity of HRT has increased dramatically in the United Kingdom in recent years, however the exact way in which it affects adipose and MASLD is unclear. The investigators will study how HRT affects the processes that drive MASLD in 10 women before and after using the treatment. This is a small-scale pilot study to understand feasibility of recruitment and test the procedures for a future, larger-scale studies. The investigators will recruit women who are about to begin HRT for the first time and perform the same tests for each participant before starting HRT, and after using HRT for 12-weeks. The participants will undergo meal testing including non-radioactive, stable isotopes, and blood and breath samples will be collected to measure fat processing. The total fat content of the liver will be measured using magnetic resonance imaging (MRI) scans. Adipose samples will be collected, fat metabolites will be measured and the distribution of fat around the body will be assessed using a dual energy x-ray absorptiometry (DEXA) scan. To find out how HRT affects these processes, the results from before and after using HRT will be compared. Understanding how HRT affects adipose and the liver may help reduce the development of MASLD in women after the menopause and improve their health and survival.
How this trial compares with your answers
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What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: Female only
What the study is looking for
- ✓Potential participant is willing and able to give agreement to take part for participation in the trial
- ✓In the Investigator's opinion, is able and willing to comply with all trial requirements
- ✓Female, aged 18 years and above
- ✓Body mass index 18 to 45 kg/m2
- ✓Postmenopausal status:
Who cannot take part
- ✗Potential participant with known chronic liver disease, with the exception of MASLD
- ✗Potential participant with any other medical explanation for amenorrhoea, apart from menopause
- ✗History of harmful alcohol consumption (\>35 units/week) or alcohol misuse disorder
- ✗Potential participants with safety concern to MRI
- ✗Scheduled elective surgery or other procedures requiring general anaesthesia during the trial.
See the full criteria
Where Is This Study? (1 UK site)
Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM), Churchill Hospital
Oxford OX3 7LE, United Kingdom
How to Get in Touch
Jiawen Dong, MB BChir, MRCP
Sponsor contactCONTACT