Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus
Recruitment status was: Recruiting
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 . Further, Kazakos et al.  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.  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.  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 . 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.
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus|
- Glycemic control [ Time Frame: For one year after treatment wih DPP-IV inhibitor ] [ Designated as safety issue: Yes ]As marker of HbA1c
- autonomic nerve disturbance [ Time Frame: Before and one year after treatment with DPP-IV inhibitor ] [ Designated as safety issue: Yes ]Before and after measurment with R-R CV in ECG at rest and respiratory deeping
|Study Start Date:||September 2011|
|Estimated Study Completion Date:||January 2013|
|Estimated Primary Completion Date:||December 2012 (Final data collection date for primary outcome measure)|
Drug: Sitagliptin, 50 mg once per day per os
Before and one year after treatment with DPP-IV inhibitor in diabetic patients with AND.
Other Name: Nothing
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545024
|Nagaoka Red Cross Hospital|
|Nagaoka, Niigata, Japan, 940-2085|
|Principal Investigator:||Kyuzi Kamoi, MD||Nagaoka Red Cross Hospital|