Effect of DPP-IV Inhibitors on Occurence of Cancers and the Mechanism Using AGE and RAGE in Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 入组人数
- 500
- 试验地点
- 2
- 主要终点
- Frequency of cancers
研究概览
简要总结
Recently, DPP-IV inhibitors are used as a novel way to augment the incretin system and one of the newest classes of medications in the treatment of type 2 diabetes mellitus (T2DM). Since the DPP-IV inhibitor was first used, about 5 years have passed in USA. However, there were no major side effects including occurrence of cancers. The main mechanism for DPP-IV inhibitors is due to suppress the function of DPP-IV activity. As it is known that the suppressed DPP-IV activity is a marker for early diagnosis of cancers, the reason of disassociation is not clear.
Activation of receptor for advanced glycation endproduct (AGE) is related to sideration of cancers. Meanwhile, the DPP-IV inhibitors may be related to inhibit the activation of receptor for AGE (RAGE). Therefore, DPP-IV inhibitors may work as a cancer protective agent in diabetes by blocking the AGE-RAGE axis.
However, it is not demonstrated why DPP-IV inhibitors have no side effect of occurrence of cancer via blocking the activation of AGE-RAGE.
The investigators examined effect of DPP-IV inhibitors on frequency of cancers and the underlying mechanism using AGE and RAGE before and 5 years after administration of DPP-IV inhibitors in Japanese patients with T2DM.
详细描述
The AGE and RAGE are measured using ELISA method in the laboratory of Department of Pathophysiology and Therapeutics of Diabetes Vascular Complications, Kurume University, School of Medicine, Japan before and for 5 years after administration of DPP-IV inhibitors.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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 2 diabetes mellitus patients with or without cancer
- •Patients who have no treatment with DPP-IV inhibitors.
- •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 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 inhibitors
干预措施: Sitagliptin (Drug)
DPP-IV inhibitors
干预措施: Alogliptin (Drug)
DPP-IV inhibitors
干预措施: Vildagliptin (Drug)
结局指标
主要结局
Frequency of cancers
时间窗: Each one year within 5 years
次要结局
- AGE concentration(Before and each one year within 5 years)
- Receptor for AGE concentration(Before and each one year within 5 years)
研究者
Kyuzi Kamoi
Medical Doctor
Nagaoka Red Cross Hospital