Post-menopausal women who are at a higher risk of conditions affecting the liver, bone and brain. Nutritional, Metabolic, Endocrine
Conditions
Interventions
The eligible participants will be first invited to the screening visit. If they agree to join the study, they will be randomly assigned to give themselves subcutaneous (under the skin) injections of
Sponsors
Imperial College London
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Women aged =40 years who are post-menopausal (i.e. absence of menstruation in the preceding 12 months with FSH levels in the post-menopausal range) as per STRAW criteria with metabolic dysfunction-associated steatotic liver disease (MASLD); and 2. Not taking any medication or stable on current medication for 3 months (i.e. no significant changes in dose, formulation or route of administration); and 3. Stable weight (i.e. up to ±6kg change in weight) for 3 months if they have not had bariatric surgery or stable weight for 12 months if they have had bariatric surgery in the preceding 24 months.
Exclusion criteria
Exclusion criteria: 1. Current and recent medications that could affect study outcomes (e.g. GLP-1, hormonal treatments, bisphosphonates); including agents used in other interventional research studies within 3 months. 2. Consumption of >17.5 units (140g) alcohol intake/week for the previous 3 consecutive months prior to screening. 3. Evidence of cirrhosis, hepatic decompensation, or other chronic liver disease apart from MASLD, or if serum alanine aminotransferase or aspartate aminotransferase are more than five times the upper limit of normal. 4. Active malignancy or ongoing treatment for malignancy. 5. Anaemia Hb<11 g/dl or other biochemical abnormality that in the opinion of the investigators could interfere with study outcomes 6. History of fracture in the last 12 months (excluding hands and feet). 7. Active significant health condition which in the opinion of the research team might interfere with the potential participants’ ability to participate and/or complete the study and/or might influence the study outcomes. 8. Taken part in any research study within the preceding 30 days (or 3 months if an investigational drug was administered)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum alanine transaminase (ALT, a marker of liver function) concentrations from baseline to 12 weeks of kisspeptin administration, measured using blood samples collected at each visit (total 8 visits) and analysed using standard laboratory techniques. | — |
Secondary
| Measure | Time frame |
|---|---|
| Other markers of liver function, including liver fat content from baseline to week 12 (as well as blood and urine markers), measured using blood samples collected at each visit (total 8 visits) and analysed using established laboratory techniques. Liver fat content will be measure using special MRI imaging in the beginning and end of the study. Exploratory outcome measures: A limited number of pre-specified exploratory outcome measures will be evaluated in sub-studies: 1. The percentage change in total osteocalcin concentration between baseline and week 12, measured using blood samples collected at each visit (total 8 visits) and analysed using established laboratory techniques. 2. Changes in markers of bone health (such as bone turnover markers and bone mineral density) from baseline to week 12, measured using blood samples collected at each visit (total 8 visits) and analysed using established laboratory techniques. Bone density will be measured using DEXA scans at the beginning and end of the study. 3. Changes in psychometric measures assessing various behavioural domains in postmenopausal health (including cognition, mood, anxiety, sociability, sexual function and quality of life) from baseline to week 12, using standardised psychometric questionnaires including WHQ, STA1-Y1, STAI-Y2, PHQ9, PANAS, MENQOL, FSFI, D2 test of attention, and Adapted Revise Cheek and Buss. | — |
Countries
England, United Kingdom
Contacts
Public ContactChioma Izzi-Engbeaya
Outcome results
None listed