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

NCT01545024 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 60

Last updated 2012-03-14

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Sitagliptin, 50 mg once per day per os

Before and one year after treatment with DPP-IV inhibitor in diabetic patients with AND.

Sponsors & Collaborators

  • Nagaoka Red Cross Hospital

    lead OTHER

Principal Investigators

  • Kyuzi Kamoi, MD · Nagaoka Red Cross Hospital

Eligibility

Min Age
20 Years
Max Age
95 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-12-31
Completion
2013-01-31

Countries

  • Japan

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01545024 on ClinicalTrials.gov