Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGSitagliptin, 50 mg once per day per os
Before and one year after treatment with DPP-IV inhibitor in diabetic patients with AND.
Sponsors
Nagaoka Red Cross Hospital
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 95 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control | For one year after treatment wih DPP-IV inhibitor | As marker of HbA1c |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Japan
Contacts
Primary ContactKyuzi Kamoi, MD
Outcome results
None listed