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

UMIN ID: UMIN000000889

Registered date:14/11/2007

Basic Information

• Recruitment status: Complete: follow-up complete
• Health condition(s) or Problem(s) studied: Chronic kidney disease (CKD) due to type-2 diabetes mellitus
• Date of first enrollment: 2007/11/01
• Target sample size: 300
• Countries of recruitment: Japan
• Study type: Observational

Outcome(s)

• Primary Outcome: Study 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 Outcome: Only 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 minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Newly 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

• Primary Sponsor: Osaka University Graduate School of Medicine
• Source(s) of Monetary Support: None