NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
UMIN ID: UMIN000000889

Registered date:14/11/2007

Case-control association study to identify key single nucleotide polymorphisms (SNPs) of cardio-renal association in type 2 diabetes.

Basic Information

Recruitment status Complete: follow-up complete
Health condition(s) or Problem(s) studiedChronic kidney disease (CKD) due to type-2 diabetes mellitus
Date of first enrollment2007/11/01
Target sample size300
Countries of recruitmentJapan
Study typeObservational
Intervention(s)

Outcome(s)

Primary OutcomeStudy 1) Of all the patients entered, compare the frequency of the gene polymorphisms between the case group and the control group. Case consists of patients with history of CVD complications at 3 months after starting hemodialysis. Control consists of those without. Study 2) Compare the frequency of the gene polymorphisms between the case group and the control group. Case consists of the patients entered to this study. Control consists of type-2 diabetic patients who do not excrete proteinuria despite more than 10-years duration of DM among the cohort we have previously collected. In the control group, age, gender and duration of disease are matched to the case. Study 3) Among the patients entered, compare the frequency of the gene polymorphisms between the case group and the control group. Case consists of patients with CVD complications (including both death and hospitalization) at 3 years after starting hemodialysis. Control consists of those without.
Secondary OutcomeOnly in the study 3, secondary outcomes are; total hospitalizations, total deaths, occlusions of arteriovenous fistula (AVF), cardio thoracic rate (CTR), and natriuretic peptides.

Key inclusion & exclusion criteria

Age minimum20years-old
Age maximum75years-old
GenderMale and Female
Include criteria
Exclude criteriaNewly entered HD patients due to benign nephroscrelosis, nephritis, hereditary renal disease and type 1 DM. Deaths within 3 months of starting dialysis. Patients who do not need dialysis any more due to recovery of renal function. Peritoneal Dialysis. Patients who are planning to undertake living kidney transplantation. Patients with malignant tumors, liver cirrhosis, immuno-deficiencies, collagen diseases and severe mental disorders.

Related Information

Contact

public contact
Name Yoshiyuki Furumatsu
Address Box A8, 2-2 Yamadaoka, Suita-city, Osaka, Japan Japan
Telephone 06-6879-3632
E-mail furumatsu@yahoo.co.jp
Affiliation Osaka University Graduate School of Medicine Nephrology
scientific contact
Name Enyu Imai
Address Box A8, 2-2 Yamadaoka, Suita-city, Osaka, Japan Japan
Telephone 06-6879-3632
E-mail
Affiliation Osaka University Graduate School of Medicine Nephrology