DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Effect of DPP-IV Inhibitors on Occurence of Cancers and the Mechanism Using AGE and RAGE in Patients With Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01588587
• Other study ID #: 7-Kamoi
• Status: Not yet recruiting
• Phase: N/A
• First received: April 26, 2012
• Last updated: October 17, 2012
• Start date: October 2012
• Est. completion date: December 2017

Study information

• Verified date: April 2012
• Source: Nagaoka Red Cross Hospital
• Contact: Kyuzi Kamoi, MD
• Phone: +81-0258-28-3600
• Email: kkam-int[@]echigo.ne.jp
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: December 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 95 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes Mellitus

Intervention

Drug:
• Sitagliptin
The dosage, frequency and duration for each sitagliptin are variant.
• Alogliptin
The dosage, frequency and duration for each alogliptin are variant.
• Vildagliptin
The dosage, frequency and duration for each vildagliptin are variant.

Locations

Country	Name	City	State
Japan	Kurume University	Kurume	Fukuoka
Japan	Nagaoka Red Cross Hospital	Nagaoka	Niigata

Sponsors (2)

Lead Sponsor	Collaborator
Nagaoka Red Cross Hospital	Kurume University

Country where clinical trial is conducted

Japan, 

References & Publications (1)

1.Gooßen K, Gräber S. Longer-term safety of DPP-4 inhibitors in patients with type 2 diabetes mellitus: systematic review and meta-analysis. Diabetes Obes Metab 2012 doi:[Epub ahead of print]. 2.Cornell S. Differentiating among incretin therapies: a multi

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of cancers		Each one year within 5 years	Yes
Secondary	AGE concentration	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.	Before and each one year within 5 years	Yes
Secondary	Receptor for AGE concentration	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	Before and each one year within 5 years	Yes