Title of research
Increasing physical exercise to preserve beta cell function in adult patients with Type 1 diabetes (EXTOD): a pilot study
Institution
University of Birmingham
Name of lead investigator
Dr Parth Narendran
Research funded by
National Institute for Health Research (NIHR)
Who to contact
Dr Amy Kennedy, Honorary Clinical Research Fellow
Tel: 07765 867 993
Email: extod@trials.bham.ac.uk
Recruiting until
December 2013
Total number of participants needed
60
Who can and cannot take part?
Participants must be newly diagnosed with Type 1 diabetes (within the last 12 weeks) and aged between 16 and 60 years of age. They must also be willing and able to self-monitor their blood glucose and record the results, take insulin injections and carry out exercise.
Participants should not already be undertaking more than 150 minutes of exercise per week, have heart disease (or be taking medication that affects heart rate) or be participating in another clinical trial.
What is the research about?
In patients with Type 1 diabetes, the insulin-producing beta cells in the pancreas are damaged and stop making insulin. Even though a significant number of these cells can still be working at the time of diagnosis, they do not make enough insulin to control blood glucose levels, and people with Type 1 therefore need insulin injections. The remaining beta cells are gradually destroyed over a number of years.
Protecting the remaining beta cells can help to control blood glucose, reduce the risk of it falling too low (hypoglycaemia) and prevent long-term complications of diabetes such as blindness and heart attacks. Evidence from studies in healthy people and people with Type 2 diabetes suggests that exercise protects beta cells. Researchers in this study will conduct a pilot study to see if this is also true for patients with Type 1.
How will it benefit people with diabetes?
For participants, the exercise involved in the study is likely to have multiple benefits, including improved well-being and a reduced risk of heart disease. If the researcher’s hypothesis is correct, it will also help to preserve beta cells, which means that participants’ diabetes might be easier to control in the long term.
If the study shows that exercise is appropriate and practical for people with newly diagnosed Type 1 diabetes and that it can help to preserve beta cell function, then it could lead to improvements in the care and guidance that such people receive.
What will taking part involve for participants?
Participants will be asked to attend a 1-2 hour interview to find out what obstacles exist to prevent them from taking regular exercise. This may be an individual interview or in a group with other patients with Type 1 diabetes.
Participants will then be placed at random in one of two groups. The first group will receive the standard diabetes care that is currently given by diabetes clinics (including written and spoken advice on exercise). The second group will receive the standard care but also be encouraged and helped to exercise at the minimum level currently recommended by the Department of Health (150 minutes a week at moderate intensity).
This group will be helped to exercise with membership to leisure centres, gyms or swimming pools and support from health advisors and diabetes nurses. They will also be given advice and guidance to ensure that this exercise does not result in low blood glucose (hypoglycaemia). They will be asked to maintain this level of exercise for one year. However, if participants find it difficult to maintain this level they can leave the study at any time.
Both the ‘exercise’ and ‘standard care’ groups will have blood tests on five occasions throughout the course of the year and some of these blood samples will be stored for future testing. Participants will also undergo urine tests and fitness tests (using an exercise bike) at the beginning, middle and end of the study. Throughout the study, all diabetes care will happen at a local information hospital, which may be different from participants’ usual hospital.
What are the risks involved in taking part?
Exercise can be associated with injury; however, the researchers will ensure that participants begin to exercise gradually in order avoid this. In people with Type 1 diabetes, prolonged exercise can contribute to a drop in blood glucose (hypoglycaemia). The researchers will avoid this by adjusting the insulin doses around the time of exercise and also by providing advice on how to treat low blood glucose levels.
Is there any compensation for taking part?
All travel expenses associated with this study will be reimbursed.