Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01545024|
Recruitment Status : Unknown
Verified February 2012 by Kyuzi Kamoi, Nagaoka Red Cross Hospital.
Recruitment status was: Recruiting
First Posted : March 6, 2012
Last Update Posted : March 14, 2012
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.
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Drug: Sitagliptin, 50 mg once per day per os|
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.
|Study Type :||Observational|
|Estimated Enrollment :||60 participants|
|Official Title:||Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus|
|Study Start Date :||September 2011|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||January 2013|
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
- Glycemic control [ Time Frame: For one year after treatment wih DPP-IV inhibitor ]As marker of HbA1c
- autonomic nerve disturbance [ Time Frame: Before and one year after treatment with DPP-IV inhibitor ]Before and after measurment with R-R CV in ECG at rest and respiratory deeping
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545024
|Contact: Kyuzi Kamoi, MDfirstname.lastname@example.org|
|Nagaoka Red Cross Hospital||Recruiting|
|Nagaoka, Niigata, Japan, 940-2085|
|Contact: Kyuzi Kamoi, MD +81-0258-28-3600 email@example.com|
|Principal Investigator: Kyuzi Kamoi, MD|
|Principal Investigator:||Kyuzi Kamoi, MD||Nagaoka Red Cross Hospital|