Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus
Rocca et al. reported first that the secretion of incretins, particular GLP-1 in rat is
regulated by the enteric nervous system, the afferent and efferent vagus nerves [1].
Further, Kazakos et al. [2] reported that autonomic nerve disturbance (AND) in patients with
T2DM impaired the incretin effect owing to decreased GLP-1 secretion. However, Toft-Nielsen
et al. [3] reported that the decreased GLP-1 responses in the patients with type 2 diabetes
mellitus (T2DM) are unlikely to be related to the AND and, thus, did not support the results
of Rocca et al. and Kazakos et al. Recently, Yabe at al. [4] also observed the same
observations in Japanese patients with T2DM. Meanwhile, Jin et al. reported that
administration of DPP-IV inhibitor recovered the disturbance of diabetic nerve dysfunction
in rat [5]. However, it is unknown whether the administration of DPP-IV inhibitor effects on
the AND in human, although many studies are performed to investigate the effect of the
DPP-IV inhibitors on glycemic control.
Accordingly, it is significant to reinvestigate an effect of DPP-IV inhibitor on glycemic
control and autonomic neuropathy in diabetic patients.
Autonomic nerve disturbance (AND) is estimated to use coefficient of variance of
electrocardiographic beat-to-beat intervals (C.V. R-R). Maximal change of the C,V. R-R with
from usual breathing to deep breathing at the resting was used for the evaluation of AND.
Less than 2.0 % of the maximal value is estimated to have a positive to AND.
Glycemic control is estimated to measure change of HbA1c value once three months per year.
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Observational Model: Case-Only, Time Perspective: Prospective
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