P Narendran1,2, N Jackson3, A Daley4, D Thompson5, K Stokes5, S Greenfield4, M Charlton2, M Curran1, T P J Solomon1, A Nouwen6, S I Lee1, A R Cooper7,8, M Mostazir9, R S Taylor10, A Kennedy1,2, R C Andrews11. 1. The Institute of Metabolism and Systems Research, Centre for Endocrinology, Diabetes and Metabolism, The Medical School, University of Birmingham, Birmingham, UK. 2. Department of Diabetes, The Queen Elizabeth Hospital, Birmingham, UK. 3. Division of Medicine, University of Bristol, Bristol, UK. 4. Institute of Applied Health Research, University of Birmingham, Birmingham, UK. 5. School for Health, University of Bath, Bath, UK. 6. Department of Psychology, School of Science and Technology, Middlesex University, London, UK. 7. Centre for Exercise, Nutrition and Health Sciences, University of Bristol, Bristol, UK. 8. NIHR Bristol Biomedical Research Unit in Nutrition, Diet and Lifestyle, University Hospitals Bristol Education and Research Centre, Bristol, UK. 9. College of Life and Environmental Sciences (CLES), University of Exeter, Exeter, UK. 10. Institute of Health Research, University of Exeter, Exeter, UK. 11. University of Exeter, Medical School, University of Exeter, Exeter, UK.
Abstract
AIM: Residual β-cell function is present at the time of diagnosis with Type 1 diabetes. Preserving this β-cell function reduces complications. We hypothesized that exercise preserves β-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 β-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 ± 3.8 kg/m2 , HbA1c 75 ± 25 mmol/mol (9 ± 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 β-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 β-cell function. (Clinical Trials Registry No; ISRCTN91388505).
RCT Entities:
AIM: Residual β-cell function is present at the time of diagnosis with Type 1 diabetes. Preserving this β-cell function reduces complications. We hypothesized that exercise preserves β-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 β-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 ± 3.8 kg/m2 , HbA1c 75 ± 25 mmol/mol (9 ± 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 β-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 β-cell function. (Clinical Trials Registry No; ISRCTN91388505).
Authors: Rhys I B Matson; Sam D Leary; Ashley R Cooper; Catherine Thompson; Parth Narendran; Rob C Andrews Journal: Front Public Health Date: 2018-12-07
Authors: Nika M D Klaprat; Nicole Askin; Andrea MacIntosh; Nicole Brunton; Jacqueline L Hay; Jane E Yardley; Seth D Marks; Kathryn M Sibley; Todd A Duhamel; Jonathan M McGavock Journal: BMJ Open Diabetes Res Care Date: 2020-03
Authors: Alice L J Carr; Richard A Oram; Shannon M Marren; Timothy J McDonald; Parth Narendran; Robert C Andrews Journal: J Endocr Soc Date: 2021-07-17
Authors: Gabriel Keine Kuga; Rafael Calais Gaspar; Vitor Rosetto Muñoz; Susana Castelo Branco Ramos Nakandakari; Leonardo Breda; Bruna Marina Sandoval; Flávio Henrique Caetano; José Alexandre Curiacos de Almeida Leme; José Rodrigo Pauli; Ricardo José Gomes Journal: Einstein (Sao Paulo) Date: 2018-08-06
Authors: Catherine Henshall; Parth Narendran; Robert C Andrews; Amanda Daley; Keith A Stokes; Amy Kennedy; Sheila Greenfield Journal: BMJ Open Date: 2018-07-17 Impact factor: 2.692