Exercise to preserve β‐cell function in recent‐onset Type 1 diabetes mellitus (EXTOD) – a randomized controlled pilot trial

Abstract

Aim Residual b-cell function is present at the time of diagnosis with Type 1 diabetes. Preserving this b-cell function reduces complications. We hypothesized that exercise preserves b-cell function in Type 1 diabetes and undertook a pilot trial to address the key uncertainties in designing a definitive trial to test this hypothesis.Methods A randomized controlled pilot trial in adults aged 16-60 years diagnosed with Type 1 diabetes within the previous 3 months was undertaken. Participants were assigned to control (usual care) or intervention (exercise consultation every month), in a 1 : 1 ratio for 12 months. The primary outcomes were recruitment rate, drop out, exercise adherence [weeks with ≥ 150 min of self-reported moderate to vigorous physical activity (MVPA)], and exercise uptake in the control group. The secondary outcomes were differences in insulin sensitivity and rate of loss of b-cell function between intervention and control at 6 and 12 months.Results Of 507 individuals who were approached, 58 (28 control, 30 intervention) entered the study and 41 completed it. Participants were largely white European males, BMI 24.8 AE 3.8 kg/m 2 , HbA 1c 75 AE 25 mmol/mol (9 AE 2%). Mean level of objectively measured MVPA increased in the intervention group (mean 243 to 273 min/week) and 61% of intervention participants reached the target of ≥ 150 min/week of self-reported MVPA on at least 42 weeks of the year. Physical activity levels fell slightly in the control group (mean 277 to 235 min of MVPA/week). There was exploratory evidence that intervention group became more insulin sensitive and required less insulin. However, the rate of loss of b-cell function appeared similar between the groups, although the change in insulin sensitivity may have affected this.Conclusion We show that it is possible to recruit and randomize people with newly diagnosed Type 1 diabetes to a trial of an exercise intervention, and increase and maintain their exercise levels for 12 months. Future trials need to incorporate measures of greater adherence to exercise training targets, and include more appropriate measures of b-cell function. (Clinical Trials

Physical activity and Type 1 diabetes: an underused therapy

“…This is the first study to have systematically attempted to translate the potential of exercise therapy into a behaviour change intervention for Type 1 diabetes that is suitable for implementation within a clinical setting. The study highlights the potential importance of this intervention, showing modest increases in levels of physical activity, cardiorespiratory fitness and insulin sensitivity , thus supporting the need for a longer‐term fully powered effectiveness trial. However, this study also highlights many of the same limitations that have been observed in behavioural interventions for Type 2 diabetes.…”

“…The Medical Research Council framework for complex interventions provides a useful blueprint for optimizing early feasibility and pilot work in the early stages of intervention development and evaluation. In this issue of Diabetic Medicine, Narendran et al [7] follow many of the steps proposed by the Medical Research Council framework in developing and piloting a pragmatic physical activity promotion intervention for those with new-onset Type 1 diabetes. This is the first study to have systematically attempted to translate the potential of exercise therapy into a behaviour change intervention for Type 1 diabetes that is suitable for implementation within a clinical setting.…”

“…The effective promotion of sustained physical activity is a clinical priority for Type 1 diabetes. The study by Narendran et al [7] gives new insight into how this may be achieved within routine clinical care, but, to be effective, it is likely that such interventions will need to employ more innovative and personalized approaches to physical activity promotion and be supported across wider clinical and societal settings.…”

Exercise and the dipeptidyl‐peptidase IV inhibitor sitagliptin do not improve beta‐cell function and glucose homeostasis in long‐lasting type 1 diabetes—A randomised open‐label study

“…In line with these findings, clinical studies in individuals with type 2 DM and healthy people showed an improvement of beta‐cell function with exercise . Nonetheless, in individuals with newly diagnosed type 1 DM, a 12‐month exercise training did not result in enhanced beta‐cell function …”

The Type 1 diabetes ‘honeymoon’ period is five times longer in men who exercise: a case–control study

“…Improved insulin sensitivity with exercise has been ª 2018 Diabetes UK demonstrated in various Type 1 diabetes populations [3]. Furthermore, recent work we have undertaken suggests that exercise improves b-cell function in Type 1 diabetes when the outcome measure is corrected for the improved insulin sensitivity that occurs with exercise [5]. Furthermore, recent work we have undertaken suggests that exercise improves b-cell function in Type 1 diabetes when the outcome measure is corrected for the improved insulin sensitivity that occurs with exercise [5].…”