Seven day remote ischaemic preconditioning improves endothelial function in patients with type 2 diabetes mellitus: a randomised pilot study
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Seven day remote ischaemic preconditioning improves endothelial function in patients with type 2 diabetes mellitus : a randomised pilot study. / Maxwell, Joseph D; Carter, Howard Henry; Hellsten, Ylva; Miller, Gemma D; Sprung, Victoria S; Cuthbertson, Daniel J; Thijssen, Dick H J; Jones, Helen.
In: European Journal of Endocrinology, Vol. 181, No. 6, 2019, p. 659-669.Research output: Contribution to journal › Journal article › Research › peer-review
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TY - JOUR
T1 - Seven day remote ischaemic preconditioning improves endothelial function in patients with type 2 diabetes mellitus
T2 - a randomised pilot study
AU - Maxwell, Joseph D
AU - Carter, Howard Henry
AU - Hellsten, Ylva
AU - Miller, Gemma D
AU - Sprung, Victoria S
AU - Cuthbertson, Daniel J
AU - Thijssen, Dick H J
AU - Jones, Helen
N1 - CURIS 2019 NEXS 371
PY - 2019
Y1 - 2019
N2 - Background: Remote ischaemic preconditioning (rIPC) may improve cardiac/cerebrovascular outcomes of ischaemic events. Ischaemic damage caused by cardiovascular/cerebrovascular disease are primary causes of mortality in type 2 diabetes mellitus (T2DM). Due to the positive effects from a bout of rIPC within the vasculature, we explored if daily rIPC could improve endothelial and cerebrovascular function. The aim of this pilot study was to obtain estimates for the change in conduit artery and cerebrovascular function following a 7-day rIPC intervention.Methods: Twenty-one patients with T2DM were randomly allocated to either 7-day daily upper-arm rIPC (4x5 min 220 mmHg, interspaced by 5-min reperfusion) or control. We examined peripheral endothelial function using flow mediated dilation (FMD) before and after ischemia-reperfusion injury (IRI, 20 min forearm ischaemic-20 min reperfusion) and cerebrovascular function, assessed by dynamic cerebral autoregulation (dCA) at three time points; pre, post and 8 days post intervention.Results: For exploratory purposes, we performed statistical analysis on our primary comparison (pre-to-post) to provide an estimate of the change in the primary and secondary outcome variables. Using pre-intervention data as a covariate, the change from pre-post in FMD was 1.3% (95%CI: 0.69 to 3.80; P=0.09) and 0.23 %cm s-1 %.mmHg-1mm Hg/% (-0.12, 0.59; P=0.18) in dCA normalised gain with rIPC versus control. Based upon this, a sample size of 20 and 50 for FMD and normalised gain, respectively, in each group would provide 90% power to detect statistically significant (P<0.05) between-group difference in a randomised controlled trial.Conclusion: We provide estimates of sample size for a randomised control trial exploring the impact of daily rIPC for 7 days on peripheral endothelial and cerebrovascular function. The directional changes outline from our pilot study suggest peripheral endothelial function can be enhanced by daily rIPC in patients with T2DM.Trial registration: ClinicalTrials.gov NCT03598855
AB - Background: Remote ischaemic preconditioning (rIPC) may improve cardiac/cerebrovascular outcomes of ischaemic events. Ischaemic damage caused by cardiovascular/cerebrovascular disease are primary causes of mortality in type 2 diabetes mellitus (T2DM). Due to the positive effects from a bout of rIPC within the vasculature, we explored if daily rIPC could improve endothelial and cerebrovascular function. The aim of this pilot study was to obtain estimates for the change in conduit artery and cerebrovascular function following a 7-day rIPC intervention.Methods: Twenty-one patients with T2DM were randomly allocated to either 7-day daily upper-arm rIPC (4x5 min 220 mmHg, interspaced by 5-min reperfusion) or control. We examined peripheral endothelial function using flow mediated dilation (FMD) before and after ischemia-reperfusion injury (IRI, 20 min forearm ischaemic-20 min reperfusion) and cerebrovascular function, assessed by dynamic cerebral autoregulation (dCA) at three time points; pre, post and 8 days post intervention.Results: For exploratory purposes, we performed statistical analysis on our primary comparison (pre-to-post) to provide an estimate of the change in the primary and secondary outcome variables. Using pre-intervention data as a covariate, the change from pre-post in FMD was 1.3% (95%CI: 0.69 to 3.80; P=0.09) and 0.23 %cm s-1 %.mmHg-1mm Hg/% (-0.12, 0.59; P=0.18) in dCA normalised gain with rIPC versus control. Based upon this, a sample size of 20 and 50 for FMD and normalised gain, respectively, in each group would provide 90% power to detect statistically significant (P<0.05) between-group difference in a randomised controlled trial.Conclusion: We provide estimates of sample size for a randomised control trial exploring the impact of daily rIPC for 7 days on peripheral endothelial and cerebrovascular function. The directional changes outline from our pilot study suggest peripheral endothelial function can be enhanced by daily rIPC in patients with T2DM.Trial registration: ClinicalTrials.gov NCT03598855
KW - Faculty of Science
KW - Remote ischaemic preconditioning
KW - Type 2 diabetes
KW - Vascular function
KW - Ischaemia reperfusion injury
U2 - 10.1530/EJE-19-0378
DO - 10.1530/EJE-19-0378
M3 - Journal article
C2 - 31614332
VL - 181
SP - 659
EP - 669
JO - European Journal of Endocrinology
JF - European Journal of Endocrinology
SN - 0804-4643
IS - 6
ER -
ID: 228852681