DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: Sitagliptin; Drug: Alogliptin; Drug: Vildagliptin

• Registration Number: NCT01588587
• Lead Sponsor: Nagaoka Red Cross Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-26
• Study First Submitted QC: 2012-04-27
• Study First Posted: 2012-05-01
• Study Start: 2012-10
• Last Update Submitted: 2012-10-17
• Last Update Posted: 2012-10-19
• Primary Completion: 2017-10
• Study Completion: 2017-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DPP-IV inhibitors	Sitagliptin	-
DPP-IV inhibitors	Alogliptin	-
DPP-IV inhibitors	Vildagliptin	-

Primary Outcome Measures

Name	Time	Method
Frequency of cancers	Each one year within 5 years

Secondary Outcome Measures

Name	Time	Method
AGE concentration	Before and each one year within 5 years	Serum AGE is measured using ELISA at the laboratory of Department pf Pathophysiology and Therapeutics of Diabetes Vascular Complications, Kurume University, which requre as 0.75 ml of serum in each patient.
Receptor for AGE concentration	Before and each one year within 5 years	Serum receptor for AGE is measured using ELISA at the laboratory of Department pf Pathophysiology and Therapeutics of Diabetes Vascular Complications, Kurume University, which requre as 0.75 ml of serum in each patient

Trial Locations

Locations (2)

Kurume University; 🇯🇵 Kurume, Fukuoka, Japan

Nagaoka Red Cross Hospital; 🇯🇵 Nagaoka, Niigata, Japan