You will be asked to come to study visits fasting (no food and drinks for 8 hours overnight, water is allowed).
Semaglutide
If you are assigned to the semaglutide treatment group, the study doctor or nurse will show you how to inject the medication into your subcutaneous tissue (the layer of tissue below your skin). You will start at a dose of 0.25 mg once a week, in order to assess tolerance to treatment. The dose of semaglutide will be increased gradually over the next 8 weeks.
Food diaries, dietary and exercise advice
Irrespective of your treatment group, we will give you a dietary and physical activity programme, which will help you in to lose weight. At two stages during the study, we will ask you to keep a record of your meals using a 3-day food diary.
Activity (‘Actigraphy’) devices
We will give you an activity device to wear as a bracelet for 7 day periods. The device is quite simple to use, and your study doctor or nurse will talk you through how it works. We will collect it from you again at visit 5.
Blood tests
At various points over the course of the study, you will have blood tests to check:
full blood count
kidney and liver function
blood sugar levels
blood fat levels
immune system
level of HIV in the immune system cells
genes responsible for your fat and sugar metabolism.
Urine and stool samples
We will ask you to give stool samples so we can study the bacteria in your gut. We will ask you to give urine samples so we can study for markers for inflammation, kidney and bone function.
Pregnancy tests
We will ask female patients to take pregnancy tests before and during the study, as pregnant women cannot be enrolled in the study. This will be either a urine or blood test.
DXA scan
This is a scan to assess your bone health and body composition (how much fat and muscle you have). The DXA scan will be done in a facility by trained staff. Your study team will give you details of where the DXA facility is located and will make arrangements for your scan.
Fibroscan
This is a special kind of ultrasound scan which allows us to measure the fat in your liver and liver stiffness.
ECG (electrocardiogram)
This is a reading of your heart activity, which is performed by placing some stickers on the skin of your chest. This is to make sure that your heart activity is not affected by the medications.
