Effect of DPP-IV Inhibitor on Glycemic Control and Autonomic Neuropathy in Adult Patients With Diabetes Mellitus
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glycemic control
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
DPP-IV inhibitor
干预措施: Sitagliptin, 50 mg once per day per os (Drug)
结局指标
主要结局
Glycemic control
时间窗: For one year after treatment wih DPP-IV inhibitor
As marker of HbA1c
次要结局
- autonomic nerve disturbance(Before and one year after treatment with DPP-IV inhibitor)
研究者
Kyuzi Kamoi
Investigator
Nagaoka Red Cross Hospital