The trial is being conducted in hospitals in the UK. If you decide to take part in MILI, your local genetics team will make a referral to a recruiting centre; usually the nearest to where you live. Your local genetics team may also be one of the recruiting centres and therefore will already have this information.
Initial Trial Visit to Main Genetics Recruitment Centre - Once referred, you will receive a letter or phone call from one of the recruitment centres to arrange an initial trial visit. You will have the opportunity to discuss the trial in more detail and to ask any questions. If you still want to enter the trial, you will be invited to sign a consent form. We will need to check that you are eligible to take part in the trial. To do this you will have: fasting blood test; pregnancy test (urine or blood) if applicable; height, weight and blood pressure measurements.
Welcome Email - You should receive an automated welcome email from the MILI team at the University of Oxford, asking to confirm which hospital you visited for the trial to check that we have your correct email address.
Quality of Life Questionnaires - After the visit, you will also be asked to complete some quality of life questionnaires, sent to you via email. The questionnaires are designed to help us learn more about how LFS affects your everyday life, such as your mental and physical wellbeing.
Randomisation Process - After your initial visit, if the test results show you are eligible, we will enter you into the randomisation process. You will be randomly allocated by computer to either the intervention arm (yearly Standard of Care MRI surveillance and metformin) or to the control arm (yearly Standard of Care MRI surveillance alone and no metformin). As the randomisation is 1:1, there is a 50% chance you will be assigned to get metformin. We will notify you in writing and may also phone you to check that you know what arm of the trial you have been randomised to.
Initial Telemed Call - Once randomised, a member of the research nurse team based at the Oxford University Hospitals NHS Foundation Trust will telephone you. They will explain to you how the telemed calls will work, talk to you about the randomisation outcome and, if you have been allocated to take metformin, they will explain the starting dose of metformin to take.
Taking Metformin - If randomised to receive metformin, you will receive a supply of metformin tablets to your home by post from our hospital pharmacy. You will need to wait for a phone call from the telemed team before you can start taking the tablets. During your first two months on the trial the metformin dose will be gradually increased every 2 weeks, managed by a member of the telemed team.
Telemed Calls (Follow-Up) - The telemed team will call you every 6 months until you complete the trial. During these calls they will check on how you are, ask you about any side effects from taking the metformin and whether you are managing to take it as prescribed (if receiving metformin). They will also ask for updates on recent medical investigations e.g., outcome of scans, other medications that you are currently taking.
Annual Visits to Recruiting Centre - While you are on the trial, you will be invited to return to see our research team at the recruitment centre where you consented to take part for a yearly check-up appointment. You will have: a fasting blood test; weight measured; discuss any changes to your skin. At the time of these visits, you will be asked via email to complete some quality of life questionnaires, if you are able.
You will remain on the trial for up to 5 years unless you decide to stop your participation or need to be withdrawn from the trial by the research team.
Taking part in this trial is entirely voluntary. If you decide to take part but change your mind, you can withdraw without giving a reason. Withdrawal from MILI will not affect your clinical care.
For further information, please contact your local genetics team.
