Type 2 Diabetes Mellitus
Conditions
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.
Interventions
DRUGSitagliptin
The dosage, frequency and duration for each sitagliptin are variant.
DRUGAlogliptin
The dosage, frequency and duration for each alogliptin are variant.
DRUGVildagliptin
The dosage, frequency and duration for each vildagliptin are variant.
Sponsors
Kurume University
Nagaoka Red Cross Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to 95 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of cancers | Each one year within 5 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Japan
Contacts
Primary ContactKyuzi Kamoi, MD
Outcome results
None listed