DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

NCT ID: NCT01588587

Last Updated: 2012-10-19

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-12-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

DPP-IV inhibitors

Sitagliptin

Intervention Type: DRUG

The dosage, frequency and duration for each sitagliptin are variant.

Alogliptin

Intervention Type: DRUG

The dosage, frequency and duration for each alogliptin are variant.

Vildagliptin

Intervention Type: DRUG

The dosage, frequency and duration for each vildagliptin are variant.

Interventions

Sitagliptin

The dosage, frequency and duration for each sitagliptin are variant.

Intervention Type: DRUG

Alogliptin

The dosage, frequency and duration for each alogliptin are variant.

Intervention Type: DRUG

Vildagliptin

The dosage, frequency and duration for each vildagliptin are variant.

Intervention Type: DRUG

Other Intervention Names

Other names are not known.; Other names are not known.; Other name is not known.

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kurume University

OTHER

Sponsor Role: collaborator

Nagaoka Red Cross Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kyuzi Kamoi

Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kyuzi Kamoi, MD

Role: PRINCIPAL_INVESTIGATOR

Nagaoka Red Cross Hospital

Locations

Kurume University

Kurume, Fukuoka, Japan

Nagaoka Red Cross Hospital

Nagaoka, Niigata, Japan

Countries

Japan

Central Contacts

Kyuzi Kamoi, MD

Role: CONTACT

Phone: +81-0258-28-3600

Email: kkam-int@echigo.ne.jp

Facility Contacts

Sho-ichi Yamagishi, MD

Role: primary

Kyuzi Kamoi, MD

Role: primary

References

1.Gooβen 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 multiple-target approach to type 2 diabetes. J Clin Pharm Ther 2012; 21:1365-2710. 3.Cordero OJ, Imbernon M, Chiara LD, Martinez-Zorzano VS, Ayude D, de la Cadena MP, Rodriguez-Berrocal FJ.Potential of soluble CD26 as a serum marker for colorectal cancer detection. World J Clin Oncol 2011;2: 245-61. 4.Taguchi A, Blood DC, del Toro G, Canet A, Lee DC, Qu W, Tanji N, Lu Y, Lalla E, Fu C, Hofmann MA, Kislinger T, Ingram M, Lu A, Tanaka H, Hori O, Ogawa S, Stern DM, Schmidt AM. Blockade of RAGE-amphoterin signalling suppresses tumour growth and metastases. Nature 2000;18;405:354-60.5.Kang R, Loux T, Tang D, Schapiro NE, Vernon P, Livesey KM, Krasinskas A, Lotze MT, Zeh HJ 3rd. The expression of the receptor for advanced glycation endproducts (RAGE) is permissive for early pancreatic neoplasia. Proc Natl Acad Sci U S A 2012 Apr 16. [Epub ahead of print].6.Ishibashi Y, Matsui T, Takeuchi M, Yamagishi S. Sitagliptin augments protective effects of GLP-1 against advanced glycation end product receptor axis in endothelial cells. Horm Metab Res 2011; 43:731-4.

Reference Type: RESULT

Other Identifiers

7-Kamoi

Identifier Type: -

Identifier Source: org_study_id