Trial ID: ISRCTN79006041
Other - Phase Unknown - No longer available
Background and study aims Type 1 diabetes (T1D) causes the level of glucose (sugar) in your blood to become too high. Some of the body’s own white blood cells attack the pancreas and stop insulin production, resulting in high blood sugar. This process is more prominent during the early stages of the disease. Regular participation in exercise is key to supporting health and wellbeing in people with T1D but it is not clear how regular exercise impacts these white blood cells in patients with new-onset T1D. This project will use a popular and effective home-based exercise program that links to the research team via a mobile phone application. We will test whether this program slows the progression of T1D by altering white bloods cells so they do not attach and enter the pancreas. Who can participate? Patients aged over 18 years who have been diagnosed with T1D within three years and that are not highly physically active (less than 150 minutes of structured exercise per week). What does the study involve? Participants will undertake a 12-week exercise intervention or control arm in a randomised order, with a 12-week study break (washout) in-between. In the exercise arm, participants will be given a wrist worn fitness watch (Polar Unite) and access to a free online training App (Polar Flow). The fitness watch will act as a personal trainer on the wrist, giving guidance and feedback during exercise on how to complete the planned sessions. The exercise sessions will consist of body weight exercises done at a high intensity (based on heart rate), with the volume of training progressively increasing throughout the 12-week period. In the control arm, participants will continue with their normal levels of activity, with heart rate monitored for each structured exercise session. Before and after exercise intervention and control arms, participants will visit a clinical research facility to donate a blood sample and undertaken various general health and diabetes measurements. What are the possible benefits and risks of participating? Benefits 1. Work from our group and Diabetes UK suggest that ≈ 70% of T1D patients do not meet the recommended exercise guidelines; however, our intervention has been shown to be effective and very popular with patients (≈ 95% adherence). This is important given that there are many barriers to exercise in patients with T1D, including fear of low blood sugar and undertaking exercise outside of their home. It is anticipated that our intervention will encourage patients to uptake this form of exercise as part of their daily lives, educate them on the use of the technology, as well as how to manage this mode of exercise around their diet and insulin injections. This study will enable us to understand how acceptable and feasible a national roll out of this exercise programme is for patients. 2. Participants will be provided with four Abbott Freestyle Libre flash glucose monitor sensors, enough to monitor glucose levels for 8 weeks over the study period. Although participants will be blinded to these during the intervention periods the data collected is likely to be useful to the participant by indicating how exercise affects the regulation of their blood sugar levels. Risks 1. Participants will exercise under our remote guidance at home for 12 weeks. Exercise can elicit low blood sugar episodes in patients with type-1 diabetes. A body of literature favours the mode of exercise used in this project (i.e., high intensity interval exercise ) over continuous moderate intensity exercise for maintaining blood glucose control during exercise. Our intervention has been validated in patients with T1D and is safe, feasible and popular with patients. We will give extensive training to patients on how to manage their diet and insulin injections around exercise. Diabetes consultants on our research team have designed an education package for patients with T1D that gives practical advice on how manipulating diet, exercise and insulin can influence blood glucose concentrations. This information will be made available to the patients in this study verbally and in a PDF document. 2. The venepuncture site of blood collection may bruise, and there is a potential for infection. We will minimize these risks by following good clinical practice and having all procedures conducted by trained, experienced phlebotomists. 3. The maximum total amount of blood taken in this study in a single day will be 50mL. It is safe to provide this amount of blood during a study visit. There are no adverse effects to expect from this procedure, and this will not prevent participants from donating blood. A conservative upper limit of no more than 125mL of blood should be drawn from any donor within a 24-hour period, and 250mL within 30-days. Withdrawing this quantity of blood is reasonable for adults of a healthy weight (≈2.5% and 5% of total blood volume (≈5 Litres) over 24-hours and 30-days respectively). Where is the study run from? University of Birmingham (UK) When is the study starting and how long is it expected to run for? February 2021 to March 2025 Who is funding the study? Rosetrees Trust (UK) Who is the main contact? Trials Email Address: extod-immune@contacts.bham.ac.uk Miss Megan Quickfall (lead researcher): vmq142@student.bham.ac.uk Dr Alex Wadley (chief investigator): A.J.Wadley@bham.ac.uk
University of Birmingham
Source: https://www.isrctn.com/