Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin, 50 mg once per day per os

• Registration Number: NCT01545024
• Lead Sponsor: Nagaoka Red Cross Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-09
• Status Verified: 2012-02
• Study First Submitted: 2012-02-23
• Study First Submitted QC: 2012-02-29
• Study First Posted: 2012-03-06
• Last Update Submitted: 2012-03-13
• Last Update Posted: 2012-03-14
• Primary Completion: 2012-12
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

type 1 and 2 diabetes mellitus patients

• Patients who have AND determined by C.V. R-R.
• Outpatients regularly visiting hospital
• Patients 20 years old (gender is disregarded)

Exclusion Criteria

Patients with a serious complication in the heart, liver or kidney

• Pregnant or possibly pregnant patients, or lactating patients
• Patients complicated with a malignant tumor at present.
• Patients participating in other clinical study.
• Other than the above, patients judged inappropriate as the subjects of this study by the investigator

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DPP-IV inhibitor	Sitagliptin, 50 mg once per day per os	-

Primary Outcome Measures

Name	Time	Method
Glycemic control	For one year after treatment wih DPP-IV inhibitor	As marker of HbA1c

Secondary Outcome Measures

Name	Time	Method
autonomic nerve disturbance	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

Trial Locations

Locations (1)

Nagaoka Red Cross Hospital; 🇯🇵 Nagaoka, Niigata, Japan