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

P. Narendran, N. Jackson, A. Daley, D. Thompson, K. Stokes, S. Greenfield, M. H. Charlton, M. C. Curran, T. P. J. Solomon, A. Nouwen, S. I. Lee, Ashley R Cooper, M. Mostazir, R. S. Taylor, A Kennedy, R. C. Andrews

Research output: Contribution to journalArticle

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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)
Original languageEnglish
Pages (from-to)1521-1531
JournalDiabetic Medicine
Volume34
Issue number11
Early online date14 Sep 2017
DOIs
Publication statusPublished - 1 Nov 2017

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Type 1 Diabetes Mellitus
Randomized Controlled Trials
Insulin Resistance
Exercise
Insulin
Control Groups
Uncertainty
Registries
Referral and Consultation
Clinical Trials

Cite this

Exercise to preserve β-cell function in recent-onset Type 1 diabetes mellitus (EXTOD) - a randomized controlled pilot trial. / Narendran, P.; Jackson, N.; Daley, A.; Thompson, D.; Stokes, K.; Greenfield, S.; Charlton, M. H.; Curran, M. C.; Solomon, T. P. J.; Nouwen, A.; Lee, S. I.; Cooper, Ashley R; Mostazir, M.; Taylor, R. S.; Kennedy, A; Andrews, R. C.

In: Diabetic Medicine, Vol. 34, No. 11, 01.11.2017, p. 1521-1531.

Research output: Contribution to journalArticle

Narendran, P, Jackson, N, Daley, A, Thompson, D, Stokes, K, Greenfield, S, Charlton, MH, Curran, MC, Solomon, TPJ, Nouwen, A, Lee, SI, Cooper, AR, Mostazir, M, Taylor, RS, Kennedy, A & Andrews, RC 2017, 'Exercise to preserve β-cell function in recent-onset Type 1 diabetes mellitus (EXTOD) - a randomized controlled pilot trial', Diabetic Medicine, vol. 34, no. 11, pp. 1521-1531. https://doi.org/10.1111/dme.13439
Narendran, P. ; Jackson, N. ; Daley, A. ; Thompson, D. ; Stokes, K. ; Greenfield, S. ; Charlton, M. H. ; Curran, M. C. ; Solomon, T. P. J. ; Nouwen, A. ; Lee, S. I. ; Cooper, Ashley R ; Mostazir, M. ; Taylor, R. S. ; Kennedy, A ; Andrews, R. C. / Exercise to preserve β-cell function in recent-onset Type 1 diabetes mellitus (EXTOD) - a randomized controlled pilot trial. In: Diabetic Medicine. 2017 ; Vol. 34, No. 11. pp. 1521-1531.
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abstract = "AimResidual 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.MethodsA 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.ResultsOf 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.ConclusionWe 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)",
author = "P. Narendran and N. Jackson and A. Daley and D. Thompson and K. Stokes and S. Greenfield and Charlton, {M. H.} and Curran, {M. C.} and Solomon, {T. P. J.} and A. Nouwen and Lee, {S. I.} and Cooper, {Ashley R} and M. Mostazir and Taylor, {R. S.} and A Kennedy and Andrews, {R. C.}",
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T1 - Exercise to preserve β-cell function in recent-onset Type 1 diabetes mellitus (EXTOD) - a randomized controlled pilot trial

AU - Narendran, P.

AU - Jackson, N.

AU - Daley, A.

AU - Thompson, D.

AU - Stokes, K.

AU - Greenfield, S.

AU - Charlton, M. H.

AU - Curran, M. C.

AU - Solomon, T. P. J.

AU - Nouwen, A.

AU - Lee, S. I.

AU - Cooper, Ashley R

AU - Mostazir, M.

AU - Taylor, R. S.

AU - Kennedy, A

AU - Andrews, R. C.

PY - 2017/11/1

Y1 - 2017/11/1

N2 - AimResidual 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.MethodsA 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.ResultsOf 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.ConclusionWe 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)

AB - AimResidual 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.MethodsA 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.ResultsOf 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.ConclusionWe 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)

UR - http://dx.doi.org/10.1111/dme.13439

U2 - 10.1111/dme.13439

DO - 10.1111/dme.13439

M3 - Article

VL - 34

SP - 1521

EP - 1531

JO - Diabetic Medicine

JF - Diabetic Medicine

SN - 0742-3071

IS - 11

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