Title: Increasing physical exercise to preserve beta cell function in adult patients with type 1 diabetes mellitus (T1DM): a pilot study (ExTOD)
Funder: Department of Health (England)

Abstract: Background T1DM results from the destruction of insulin secreting beta cells. The symptoms of T1DM develop and the diagnosis is made when 50-75% of beta cell function has been lost. Preservation of this residual beta cell function will improve diabetes control and reduce the risk of diabetes complications and hypoglycaemia, all endpoints which patients tell us are important. There is now strong evidence from studies of healthy people and those with type 2 diabetes (T2DM) that exercise preserves beta cell function. Barriers to initiation and adherence to exercise have been partially studied in children with T1DM, and one small study has been conducted in North American adults with T1DM, but research is also urgently needed to validate these findings in adult patients with T1D in the UK. Aims Our overarching aim is to encourage newly diagnosed T1DM patients to take up and adhere to a programme of intensive exercise and explore whether this intervention preserves beta cell function. This application is a pilot study to 1) identify barriers to the uptake and adherence to an intensive exercise programme which aims to encourage T1DM patients to safely increase and maintain their exercise level to at least 150mins/week. 2) determine the percentage of patients with T1DM who would be willing to take part in an exercise study, and define the rates of exercise adherence and drop out 3) determine the rate of exercise uptake in the non-intervention arm 4) determine the rate of loss of beta cell function (effect size) to enable the power calculations for the definitive trial to be refined Plan of Investigation We will follow the MRC Framework for the design and evaluation of complex interventions. Phase 1: We will assess barriers to initiation and adherence to exercise in 80 patients with T1DM, and their preferences for its form, delivery and supervision. Phase 2: 60 patients newly diagnosed patients with T1DM will be recruited from local research networks and randomised to either conventional treatment or intervention (conventional treatment and exercise). Exercise will be supervised, graded and for a minimum of 150mins/week aiming for 240mins/week for 6 months. Primary outcomes will be recruitment, adherence and loss to follow-up rates. Secondary outcome will be beta cell function. Phase 3: Definitive trial of exercise on beta cell function in T1DM - not the basis of this application Potential Impact Exercise will help patients with T1D through improvements in • insulin sensitivity & weight, resulting in lower insulin doses, cholesterol and blood pressure • risks of stroke and heart disease, the commonest cause of T1DM deaths in the UK • well being and mental health. Depression is common in patients with T1DM • reduction in osteoporosis, osteoarthritis and certain cancers Despite this evidence, most patients with T1DM do not undertake the minimum of 150mins per week of exercise currently recommended by the Chief Medical Officer (CMO) in the ‘At least five a week’ report’[1]. Phase 1 will explore barriers to exercise in patients with T1DM. Phase 2 will provide the data to design and power a definitive randomised control study of exercise and preservation of beta cell function.


Research activity codes: 6.7 PHYSICAL
Health categories: METABOLIC AND ENDOCRINE