COHORT-MASLD: pilot
Research type
Research Study
Full title
COmmencing menopausal HOrmone Replacement Therapy and the effect on Metabolic-dysfunction Associated Steatotic Liver Disease: a pilot mechanistic study
IRAS ID
345429
Contact name
Jeremy Tomlinson
Contact email
Sponsor organisation
University of Oxford
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 2 months, 26 days
Research summary
Metabolic dysfunction-associated steatotic liver disease (MASLD) affects 1-in-4 people globally, and the death rate in women is rising faster than in men. MASLD is a condition of fat build-up in the liver that can progress to liver scarring and is associated with higher chances of death. Women are more than twice as likely to develop MASLD after menopause compared to before menopause, and this may be caused by a lack of oestrogen. Oestrogen contained in hormone replacement therapy (HRT) is an effective treatment for hot flushes and other problems in menopause. In Oxfordshire, HRT prescriptions have increased by 300% since 2019 and there is an urgent need to study how HRT affects processes that lead to MASLD. We will study how HRT affects the build-up and removal of fat in the liver by investigating these processes in 10 women before and after using the treatment. This is a small-scale study to understand feasibility of recruitment and test the procedures for a future, larger-scale studies.
We 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 be asked to consume water and food containing non-radioactive isotopes, and blood and breath samples will be collected. Then the amount of isotope in these samples will be measured to work out how much fat is being produced and removed in the liver. The total fat content of the liver will be measured using magnetic resonance imaging (MRI) scans. To find out how HRT affects the above processes, the results from before and after using HRT will be compared. Understanding how HRT affects the liver may help reduce the development of MASLD in women after the menopause and improve their health and survival.
REC name
South Central - Hampshire B Research Ethics Committee
REC reference
24/SC/0305
Date of REC Opinion
22 Oct 2024
REC opinion
Further Information Favourable Opinion