Clinical trials

The goal of this observational study is to understand how diet may influence the disease characteristics of inclusion body myositis (IBM). Research findings will help determine whether dietary factors could play a role in managing IBM. The study aims to answer the question: Does diet affect the muscle health and functional ability of people living with IBM? Researchers will compare adults with IBM to healthy volunteers aged 40 years and older. This comparison will help to identify which findings are related to normal ageing and which are specific to IBM. Participants will: Attend an initial screening visit at the Manchester Metropolitan University Institute of Sport to confirm eligibility and explain study procedures. Complete four weeks of home-based monitoring, including dietary records, physical activity monitoring, and questionnaires about lifestyle and symptoms. Attend a second university visit for assessments of body composition, metabolism, and muscle function.

This study is looking at whether eating a breakfast which has two different sources of carbohydrates, glucose and fructose (found in foods like honey and fruits), can increase how much glycogen can be stored in the liver. Glucose is a type of sugar that the body uses to provide energy during exercise. When it is not circulating in the blood, it is stored in the muscles and liver. The stored version of glucose is often referred to as glycogen. When the body needs energy, for example, it will break down glycogen into glucose so that it can be used as fuel. Muscle and liver glycogen stores are vital in providing energy during prolonged exercise, and strenuous activity can rapidly deplete these stores, leading to increased fatigue and a decline in performance. Liver glycogen, however, is particularly important because it controls blood glucose levels. This is important because the brain and other organs are constantly relying on the supply of glucose to function properly. When sleeping, the body goes through a natural period of fasting. During this period, the liver gradually breaks down its glycogen stores to release glucose into the bloodstream. Because of this, following sleep, liver glycogen stores are automatically low (which is why having breakfast is important). There is research to suggest that eating a high-carbohydrate breakfast can prevent further declines in liver glycogen; however, it is not known if eating different types of carbohydrates within the breakfast (glucose and fructose together) will affect the liver's ability to store glycogen. This research will aid in understanding optimal ways to increase liver glycogen stores before performing exercise, which may influence exercise performance. Therefore, the main aim of this study is: 1\. Investigate whether a high fructose breakfast will increase liver glycogen storage To achieve this, participants will be recruited to complete a randomised crossover study where they will undertake three different conditions. All laboratory trials will take place at the Manchester Metropolitan University Institute of Sport. 1. No breakfast (Control) 2. 3 g/kg of body mass of carbohydrate (of which contains 0% fructose) 3. 3 g/kg of body mass of carbohydrate (of which contains50% fructose) Liver glycogen stores will be measured using magnetic resonance imaging (MRI) and magnetic resonance spectroscopy (MRS). The investigators will measure liver glycogen content, liver volume, and stomach volume. Blood samples will also be taken to measure different metabolic hormone responses.

The purpose of the study is to assess the efficacy of a novel 8 week heat therapy intervention in intermittent claudication compared to usual care controls. Participants will be enrolled on a wait-list control randomised trial testing physiological, mechanistic, and health related outcome measures.

This study is a proof-of-concept randomised controlled trial (RCT). The goal of the study is to investigate the effectiveness of a feedback intervention to improve use of the accelerator pedal in patients driving with diabetes and peripheral neuropathy (DPN). The main (primary) question it aims to answer is: What is the effect of a visual feedback intervention (over 6 sessions a month apart), compared to no feedback, on accelerator pedal use by drivers with diabetic peripheral neuropathy? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time with the accelerator pedal pushed down further than 9 degrees (about halfway down), the point at which the visual feedback (a warning signal) is triggered. Secondary research questions are: 1. What is the effect of the feedback intervention on drivers with diabetic peripheral neuropathy at the first visit, and at the third visit? When does the biggest improvement happen? Our working hypothesis is that the visual feedback intervention will reduce the % of drive time spent driving with the accelerator pedal pushed down further than 9 degrees, the point at which the feedback is triggered, in the first visit (ie with the first exposure to feedback) and by additional amounts in subsequent visits ie there will be an immediate benefit, and additional benefits that accrue gradually with repetition over the 6 monthly visits. 2. What is the effect of the feedback intervention on a second variable, % of drive time with the vehicle 'out of control'. Out of control is defined as extreme use of the steering wheel, large and rapid movements that reach the full range of motion of the steering wheel or large swings back and forth together with excursion out of lane which the driver fails to prevent. Our working hypothesis is that the visual feedback intervention will reduce the % of drive time with the vehicle out of control. Researchers will compare the group of drivers with neuropathy who receive the intervention with a control group who do not. In addition, a group of drivers who have diabetes but no diagnosed neuropathy will be studied. This is to seek confirmatory evidence (previously seen in a small sample in a previous study) that most drivers who have no diagnosed neuropathy do not push the accelerator pedal down more than 9 degrees and so do not need to improve their use of the accelerator pedal. Participants will have their driving assessed in a driving simulator. Participants with DPN who push the accelerator pedal down more than 9 degrees will then be randomly allocated to the intervention group or control group. Only drivers in the intervention group will go on to experience the visual feedback intervention (in 6 sessions a month apart). Drivers in the control group will have their driving assessed at their first visit, and then at two later visits timed to coincide with the 3rd and 6th visit by drivers in the intervention group. This is the minimum necessary to be able to compare their driving with the intervention group at the start, midpoint and end of the intervention.