RecruitingPHASE1INTERVENTIONAL

COmmencing Menopausal HOrmone Replacement Therapy and the Effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a Pilot Mechanistic Study

This study aims to understand how Hormone Replacement Therapy (HRT) affects fat build-up in the liver and throughout the body in women starting HRT for the first time. Fatty liver disease, known as MASLD, is becoming more common, especially in women after menopause. Researchers believe that the drop in oestrogen levels during menopause might play a role in developing MASLD. HRT can help with menopausal symptoms, but its impact on liver and body fat is not fully clear. This small pilot study will follow 10 women, taking measurements before and after 12 weeks of HRT, to see how it affects fat processing and distribution, and liver fat content. The findings could help reduce the risk of MASLD in menopausal women.

At a glance

Status

Recruiting

Phase

PHASE1

Sponsor

University of Oxford

Enrolment target

Start

01 Jan 2025

Estimated completion

01 Jan 2026

Menopause Metabolic Dysfunction Associated Steatotic Liver Disease

What is this study about?

This study is looking into how Hormone Replacement Therapy (HRT) affects certain health aspects in women going through menopause. Specifically, it's focusing on a condition called Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD), which is essentially fat gathering in the liver. This condition is very common globally, affecting about one in four people, and it can become serious if it leads to liver scarring. We know that MASLD tends to be more common in women after menopause compared to before, and it's thought that the drop in oestrogen, a female hormone, might be a reason for this. This drop in oestrogen can also change how the body handles fat, which is important in how MASLD develops.

HRT is a well-known treatment for many menopausal symptoms like hot flushes, and its use has become more common in the UK. However, we don't fully understand exactly how HRT impacts liver fat and overall body fat. This study aims to shed light on these processes. By understanding these effects, researchers hope to find ways to reduce the risk of MASLD in women after menopause, which could lead to better long-term health.

This is a small, initial study involving 10 women. Its main purpose is to test the methods and see if larger studies are practical in the future. The information gathered will be crucial in designing bigger research projects to get a clearer picture of HRT's role in liver health during menopause.

Key takeaways

Investigation into HRT's effect on liver fat.
Focus on post-menopausal women and MASLD.
Small pilot study to test methods for future research.
Involves scans, meal tests, and body fat samples.
Aims to understand general health benefits of HRT.
Information helps reduce future MASLD risk.

Who may be eligible?

This study is looking for women aged 18 and over who are starting HRT for the very first time. You would need to be past menopause (either naturally or due to surgery) and not have used any oestrogen-based HRT in the last three months. You should generally be in good health and not have serious medical conditions that would affect the study.

There are also some things that would mean you couldn't take part. For example, if you have other serious liver diseases (apart from MASLD), or if you're taking medications that could significantly affect your liver fat. People with a history of heavy drinking, or those who can't have an MRI scan, would also not be able to participate. The research team will carefully check if this study is right for you, ensuring your safety and the accuracy of the study results.

Quick self-check

Are you a woman aged 18 or over?
Are you past menopause (naturally or surgically)?
Are you about to start HRT for the first time, or haven't used it in the last 3 months?
Do you have a BMI between 18 and 45?
Do you have MASLD, but no other serious liver conditions?
Are you generally in good health and able to attend clinic visits?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you take part in this study, the research team will ask you to visit the clinic on a few occasions. You will have a series of tests performed twice: once before you start your HRT, and then again after you've been taking HRT for 12 weeks. These tests will include a special 'meal test' where you'll eat a prepared meal containing harmless, non-radioactive markers. Blood and breath samples will be collected to help understand how your body processes fats.

You will also have two types of scans: an MRI scan to measure the amount of fat in your liver, and a DEXA scan to look at how fat is distributed around your body. Additionally, small samples of your body fat will be taken (this is a minor procedure). The total duration of your active participation will be around 12 weeks, plus the initial screening and follow-up appointment. There will be no specific medication given as part of the study itself; you will simply be taking the HRT prescribed by your doctor as you normally would, and the study will observe its effects.

Potential risks and benefits

Taking part in this study may offer some potential benefits, such as gaining a better understanding of your own body's fat processing and liver health through the detailed scans and tests. While this is a pilot study and doesn't aim to directly improve your health, the information gathered could help future women by leading to a clearer understanding of how HRT impacts liver health. Potential risks are generally minor and associated with the procedures involved, such as discomfort from blood draws, breath tests, and the small fat sample collection, as well as the standard considerations for MRI and DEXA scans. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

Oxford Centre for Diabetes Endocrinology and Metabolism (OCDEM), Churchill Hospital
Oxford, United Kingdom· Recruiting

Common questions

What is MASLD?

MASLD stands for Metabolic Dysfunction-Associated Steatotic Liver Disease. It's a common condition where too much fat builds up in your liver.

Why is this study only for women?

This study focuses on women because MASLD becomes more common after menopause, and researchers want to understand if the drop in female hormones like oestrogen plays a role.

Will I receive HRT from the study?

No, you will be starting HRT as prescribed by your own doctor, and the study will then look at its effects on your body.

Are the tests safe?

Yes, the tests like MRI, DEXA, blood, and breath samples are standard medical procedures and considered safe. The fat sample is a minor procedure.

How long will I be involved in the study?

Your active involvement with clinic visits and tests will be over approximately 12 weeks, with tests done at the beginning and end of this period.

How to find out more

Jiawen Dong, MB BChir, MRCP

jiawen.dong@ocdem.ox.ac.uk +441865 857300 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.