DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2012 by Nagaoka Red Cross Hospital
Sponsor:
Collaborator:
Kurume University
Information provided by (Responsible Party):
Kyuzi Kamoi, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier:
NCT01588587
First received: April 26, 2012
Last updated: October 17, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention
Type 2 Diabetes Mellitus
Drug: Sitagliptin
Drug: Alogliptin
Drug: Vildagliptin

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Effect of DPP-IV Inhibitors on Occurence of Cancers and the Mechanism Using AGE and RAGE in Patients With Type 2 Diabetes

Resource links provided by NLM:


Further study details as provided by Nagaoka Red Cross Hospital:

Primary Outcome Measures:
  • Frequency of cancers [ Time Frame: Each one year within 5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • AGE concentration [ Time Frame: Before and each one year within 5 years ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Before and each one year within 5 years ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 500
Study Start Date: October 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: October 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
DPP-IV inhibitors Drug: Sitagliptin
The dosage, frequency and duration for each sitagliptin are variant.
Other Name: Other names are not known.
Drug: Alogliptin
The dosage, frequency and duration for each alogliptin are variant.
Other Name: Other names are not known.
Drug: Vildagliptin
The dosage, frequency and duration for each vildagliptin are variant.
Other Name: Other name is not known.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 95 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

500 patients

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588587

Contacts
Contact: Kyuzi Kamoi, MD +81-0258-28-3600 kkam-int@echigo.ne.jp

Locations
Japan
Kurume University Not yet recruiting
Kurume, Fukuoka, Japan, 830-0111
Contact: Sho-ichi Yamagishi, MD    +81-942-31-7873    shoichi@med.kurume-u.ac.jp   
Sub-Investigator: Sho-ichi Yamagishi, MD         
Nagaoka Red Cross Hospital Not yet recruiting
Nagaoka, Niigata, Japan, 940-2085
Contact: Kyuzi Kamoi, MD    +81-0258-28-3600    kkam-int@echogo.ne.jp   
Principal Investigator: Kyuzi Kamoi, MD         
Sub-Investigator: Sho-ichi Yamagishi, MD         
Sponsors and Collaborators
Nagaoka Red Cross Hospital
Kurume University
Investigators
Principal Investigator: Kyuzi Kamoi, MD Nagaoka Red Cross Hospital
  More Information

No publications provided

Responsible Party: Kyuzi Kamoi, Medical Doctor, Nagaoka Red Cross Hospital
ClinicalTrials.gov Identifier: NCT01588587     History of Changes
Other Study ID Numbers: 7-Kamoi
Study First Received: April 26, 2012
Last Updated: October 17, 2012
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Vildagliptin
Sitagliptin
Alogliptin
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 22, 2014