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

Sponsor
Nagaoka Red Cross Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01545024
Collaborator
(none)
60
Enrollment
1
Location
16
Duration (Months)
3.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Sitagliptin, 50 mg once per day per os

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 Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
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
Study Start Date :
Sep 1, 2011
Anticipated Primary Completion Date :
Dec 1, 2012
Anticipated Study Completion Date :
Jan 1, 2013

Arms and Interventions

Arm Intervention/Treatment
DPP-IV inhibitor

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 Names:
  • Nothing

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Glycemic control [For one year after treatment wih DPP-IV inhibitor]

      As marker of HbA1c

    Secondary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 95 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Nagaoka Red Cross Hospital Nagaoka Niigata Japan 940-2085

    Sponsors and Collaborators

    • Nagaoka Red Cross Hospital

    Investigators

    • Principal Investigator: Kyuzi Kamoi, MD, Nagaoka Red Cross Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kyuzi Kamoi, Investigator, Nagaoka Red Cross Hospital
    ClinicalTrials.gov Identifier:
    NCT01545024
    Other Study ID Numbers:
    • 4-Kamoi
    First Posted:
    Mar 6, 2012
    Last Update Posted:
    Mar 14, 2012
    Last Verified:
    Feb 1, 2012
    Additional relevant MeSH terms:
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Sitagliptin Phosphate

    Study Results

    No Results Posted as of Mar 14, 2012