UMIN-CTR Clinical Trial

Basic information
Public title	Genome-wide case-control association study to identify susceptibility gene to diabetic nephropathy using single nucleotide polymorphisms.
Acronym	Study for susceptibility gene to diabetic nephropathy
Scientific Title	Genome-wide case-control association study to identify susceptibility gene to diabetic nephropathy using single nucleotide polymorphisms.
Scientific Title:Acronym	Study for susceptibility gene to diabetic nephropathy
Region	Japan

Condition
Condition	Diabetic nephropathy
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	Diabetic nephropathy is the leading cause of end-stage renal disease, accounting for 25% of the patients receiving chronic dialysis therapy. The number of the patients with diabetic nephropathy is expected to continue to increase progressively, giving a serious concern in terms of medical economy. Recently, a large scale genetic approach may be a useful to identify loci involved in the susceptibility for common disorders, as well as in the responsiveness or side-effect of several drugs. Then, in this study to identify genes conferring susceptibility to diabetic nephropathy, we will perform a genomic-wide case-control association study using single nucleotide polymorphisms as genetic markers. Our goal is to provide the evidence showing the novel mechanism of the disease, and to obtain a useful target for new drugs to aid in the prevention and treatment of diabetic nephropathy.
Basic objectives2	Others
Basic objectives -Others	This study explores genes associated with the development and progress of diabetic nephropathy using a database for several hundred thousands of polymorphic markers existing on entire human genome. The results of this study will be expected to establish a method for the prevention and treatment of diabetic nephropathy.
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Diabetic patients with diabetic retinopathy were divided into two groups: 1) nephropathy cases (DN):-patients with overt nephropathy, 2) controls (C):-patients showing no evidence of renal dysfunction (based on the urinary albumin levels). Our first screening involved genotyping 94 DNs and 94 Cs for 10,000 SNP loci, and we further analyzed the SNP loci showing significant differences in allelic frequencies between DN and C using a larger number of patients.
Key secondary outcomes

Base
Study type	Observational

Study design
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Intervention
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Eligibility
Age-lower limit	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Type 2 diabetic patients were divided into two groups according to the stage of diabetic nephropathy and diabetic retinopathy. 1) Nephropathy cases:Patients with diabetic retinopathy as well as overt nephropathy, urinary albumin excretion rates (AER) greater than 200 micro-g/min or urinary albumin/creatinine rations (Alb/Cr) greater than 300 mg/gCr, or patients under chronic renal-replacement therapy. 2) Control:Patients with diabetic retinopathy but without any sign of renal dysfunction, AER less than 20 micro-g/min or Alb/Cr less than 30 mg/gCr.
Key exclusion criteria	Patients with other chronic renal diseases.
Target sample size	2000

Research contact person
Name of lead principal investigator	1st name Middle name Last name Shiro Maeda
Organization	SNP Research Center, RIKEN
Division name	Laboratory for Diabetic Nephropathy
Zip code
Address	1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa 230-0045, Japan
TEL	045-503-9595
Email

Public contact
Name of contact person	1st name Middle name Last name Shiro Maeda
Organization	SNP Research Center, RIKEN
Division name	Laboratory for Diabetic Nephropathy
Zip code
Address	1-7-22 Suehiro-cho, Tsurumi-ku, Yokohama, Kanagawa 230-0045, Japan
TEL	045-503-9595
Homepage URL
Email	smaeda@src.riken.jp

Sponsor
Institute	RIKEN
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Funding Source
Organization	RIKEN
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Nationality of Funding Organization	Japan

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IRB Contact (For public release)
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Secondary IDs
Secondary IDs	NO
Study ID_1
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Study ID_2
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IND to MHLW

Institutions
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Other administrative information
Date of disclosure of the study information	2005 Year 11 Month 15 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
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Progress
Recruitment status
Date of protocol fixation	2001 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2001 Year 06 Month 01 Day
Last follow-up date	2010 Year 03 Month 01 Day
Date of closure to data entry	2010 Year 03 Month 01 Day
Date trial data considered complete
Date analysis concluded	2010 Year 03 Month 01 Day

Other

Other related information

81,315 SNP loci were successfully genotyped, and about 1,600 SNP loci were found to be statiscally significant (p<0.01). These SNP loci were analyzed further in a larger number of subjects to clarify their statistical significance. As a result, we could identify SLC12A3 and ELMO1 as novel candidates for conferring susceptibility to diabetic nephropathy. We are also examining other candidate loci (p<0.0001).

Management information
Registered date	2005 Year 10 Month 31 Day
Last modified on	2008 Year 10 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000341

Research Plan
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Research case data specifications
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Research case data
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