DPP-IV Inhibitors Underlying Mechanism of Cancer in Diabetic Patients
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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 |
- Frequency of cancers [ Time Frame: Each one year within 5 years ] [ Designated as safety issue: Yes ]
- 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 |
500 patients
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| Contact: Kyuzi Kamoi, MD | +81-0258-28-3600 | kkam-int@echigo.ne.jp |
| 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 | |
| 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 May 19, 2013