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Recruitment status
Unique ID issued by UMIN C000000272
Receipt No. R000000341
Scientific Title Genome-wide case-control association study to identify susceptibility gene to diabetic nephropathy using single nucleotide polymorphisms.
Date of disclosure of the study information 2005/11/15
Last modified on 2008/10/21

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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
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
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Interventions/Control_9
Interventions/Control_10

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
Institute
Department

Funding Source
Organization RIKEN
Organization
Division
Category of Funding Organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

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
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

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
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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