Trial ID: ISRCTN13193281
Other - Phase Unknown - No longer available
Background and study aims There are 3.7 million people in the UK with diagnosed diabetes (both Type 1 and Type 2), with approximately 80% treated with insulin or requiring insulin treatment at some stage of the disease. While diabetes complications such as cardiovascular disease are well known, often unappreciated complications are the accelerated rate of sarcopenia (loss of bone mass), increased frailty, and loss of independence that can come from years of exposure to hyperglycaemia and inflammation. Leading a physically active life can be problematic for those with insulin-treated diabetes due to blood glucose control disruption. However, resistance (weight) training carries less risk of a loss of blood glucose control, compared to other forms of exercise. Moreover, in other groups of people with frailty, resistance training has been shown effective in improving physical function. With the increasing prevalence of diabetes, planning for the management of this patient group in later life is vital. The aim of this study is to test the use of resistance exercise to improve physical function in older patients with insulin treated diabetes, who are mildly frail. This study also aims to increase understanding of the impact of resistance training on patients with diabetes psycho-socially. Findings will be used to inform a future trial should the training prove acceptable and feasible. Who can participate? Thirty patients with insulin-treated diabetes (type 1 and 2), and thirty without (matched for age and frailty), aged 60 or over, will be recruited. What does the study involve? All participants will complete blood and physical testing. Fifteen of each group will then be randomised to a four-week supervised resistance training programme, designed to increase muscle mass/strength. All participants will then repeat the physical testing. A subset will be interviewed before and after the training programme to understand their perceptions of training, and living with diabetes (where relevant) as they have aged. What are the possible benefits and risks of participating? There is no direct benefit for participants. However, exercise is repeatedly shown to be of benefit, both physically and mentally. All participants will be screened before taking part in the study, to ensure that they do not have any conditions which exercise may exacerbate. This is to ensure safety. The resistance training programme is designed to be accessible to all, building gradually over the four week period. Participants will be fully supervised, and weights will be adjusted to what they can easily lift (rather than a specific kilogram weight). Blood samples will be taken as part of the study, there is the risk of slight discomfort or bruising. These risks will be minimised by samples being taken by experienced clinical staff. The study requires frequent visits to the CRF which may cause a time inconvenience for participants. Participants will be reimbursed £50 for taking part in the study as compensation for their time. Transportation will be provided for all visits. Participants' visits will also be scheduled at the convenience of the participant, such that any inconvenience is minimised. Where is the study run from? Newcastle University (UK) and the Clinical Research Facility at the Royal Victoria Infirmary, Newcastle-upon-Tyne (UK) When is the study starting and how long is it expected to run for? From December 2019 to April 2025 Who is funding the study? Internal Newcastle University funding supported by the Wellcome Trust small grant scheme (UK) Who is the main contact? Dr Daniel West daniel.west@newcastle.ac.uk
Newcastle upon Tyne Hospitals NHS Foundation Trust
Source: https://www.isrctn.com/