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

This study is currently recruiting participants.
Verified February 2012 by Nagaoka Red Cross Hospital
Sponsor:
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT01545024
First received: February 23, 2012
Last updated: March 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
 Drug: Sitagliptin, 50 mg once per day per os

Study Type: Observational
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • Glycemic control [ Time Frame: For one year after treatment wih DPP-IV inhibitor ] [ Designated as safety issue: Yes ]
    As marker of HbA1c


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 60
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)
Groups/Cohorts Assigned Interventions
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 Name: Nothing

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Type 1 and 2 diabetic patients who have AND determined by C.V. R-R, outpatients regularly visiting hospital and more than 20 years old (gender is disregarded). Type 1 diabetic patients are treated with Epalrestat 50 mg. 150 mg t.i.d., while type 2 diabetic patients are treated with DPP-IV inhibitors.

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545024

Contacts
Contact: Kyuzi Kamoi, MD -81-0258-28-3600 kkam-int@echigo.ne.jp

Locations
Japan
Nagaoka Red Cross Hospital Recruiting
Nagaoka, Niigata, Japan, 940-2085
Contact: Kyuzi Kamoi, MD     +81-0258-28-3600     kkam-int@echigo.ne.jp    
Principal Investigator: Kyuzi Kamoi, MD            
Sponsors and Collaborators
Nagaoka Red Cross Hospital
Investigators
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
  More Information

No publications provided

Responsible Party: Kyuzi Kamoi, Investigator, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01545024     History of Changes
Other Study ID Numbers: 4-Kamoi
Study First Received: February 23, 2012
Last Updated: March 13, 2012
Health Authority: United States: Food and Drug Administration
Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Nervous System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
 Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 19, 2013