DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

NCT01588587 | Unknown

• 1 other identifier: 7-Kamoi
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 2

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.

Conditions

Type 2 Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

• Frequency of cancers

  Each one year within 5 years

Secondary Outcomes (2)

• AGE concentration

  Before and each one year within 5 years

• Receptor for AGE concentration

  Before and each one year within 5 years

Study Arms (1)

DPP-IV inhibitors

Drug: Sitagliptin; Drug: Alogliptin; Drug: Vildagliptin

Interventions

Sitagliptin DRUG

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

Also known as: Other names are not known.

DPP-IV inhibitors

Alogliptin DRUG

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

Also known as: Other names are not known.

DPP-IV inhibitors

Vildagliptin DRUG

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

Also known as: Other name is not known.

DPP-IV inhibitors

Eligibility Criteria

• Age: 20 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

500 patients

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Nagaoka Red Cross Hospital: lead
• Kurume University: collaborator

Study Sites (2)

Kurume University

Kurume, Fukuoka, 830-0111, Japan

Location

Nagaoka Red Cross Hospital

Nagaoka, Niigata, 940-2085, Japan

Location

Related Publications (1)

• 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.

  RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate; alogliptin; Vildagliptin

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrazines; Nitriles; Organic Chemicals; Pyrrolidines

Study Officials

• Kyuzi Kamoi, MD

  Nagaoka Red Cross Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyuzi Kamoi, MD

CONTACT

+81-0258-28-3600; kkam-int@echigo.ne.jp

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor

Study Record Dates

• First Submitted: April 26, 2012
• First Posted: May 1, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2017
• Study Completion: December 1, 2017
• Last Updated: October 19, 2012

Record last verified: 2012-04

Locations

JP (2)