UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000889 |
|---|---|
| Receipt number | R000001071 |
| Scientific Title | Case-control association study to identify key single nucleotide polymorphisms (SNPs) of cardio-renal association in type 2 diabetes. |
| Date of disclosure of the study information | 2007/11/14 |
| Last modified on | 2008/12/09 11:07:18 |
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Basic information
Public title
Case-control association study to identify key single nucleotide polymorphisms (SNPs) of cardio-renal association in type 2 diabetes.
Acronym
SNPs of Cardio-Renal Association in Type 2 Diabetes: SOCRATES
Scientific Title
Case-control association study to identify key single nucleotide polymorphisms (SNPs) of cardio-renal association in type 2 diabetes.
Scientific Title:Acronym
SNPs of Cardio-Renal Association in Type 2 Diabetes: SOCRATES
Region
| Japan |
Condition
Condition
Chronic kidney disease (CKD) due to type-2 diabetes mellitus
Classification by specialty
| Cardiology | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Identify key SNPs of cardio-renal association.
Basic objectives2
Others
Basic objectives -Others
Purpose of this study is to find gene polymorphisms which are related to progressions of cardio-vascular disease (CVD) and chronic kidney disease (CKD) in type 2 diabetic CKD patients. In our cohort, we survey 100 SNPs (including insertion/ deletion) correlated with atheloscrelosis, inflammation, renin-angiotensin-aldosterone system, fibrolytic system and etc. simultaneously.
Purpose 1) Identify gene polymorphisms which have associations with CVD complications in the beginning of hemodialysis (HD) in patients with type 2 diabetes.
Purpose 2) Identify gene polymorphisms which have associations with progression to end-stage renal disease (ESRD) in patients with type 2 diabetes.
Purpose 3) Identify gene polymorphisms which have associations with CVD complications in HD patients due to type 2 diabetic nephropathy.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
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.
Key secondary outcomes
Only in the study 3, secondary outcomes are; total hospitalizations, total deaths, occlusions of arteriovenous fistula (AVF), cardio thoracic rate (CTR), and natriuretic peptides.
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
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients who have newly entered maintenance hemo-dialysis after at least 10 years duration of DM. Absence of diabetic retinopathy can be included.
Key exclusion 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.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Enyu Imai |
Organization
Osaka University Graduate School of Medicine
Division name
Nephrology
Zip code
Address
Box A8, 2-2 Yamadaoka, Suita-city, Osaka, Japan
TEL
06-6879-3632
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshiyuki Furumatsu |
Organization
Osaka University Graduate School of Medicine
Division name
Nephrology
Zip code
Address
Box A8, 2-2 Yamadaoka, Suita-city, Osaka, Japan
TEL
06-6879-3632
Homepage URL
furumatsu@yahoo.co.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 2007 | Year | 11 | Month | 14 | 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
Terminated
Date of protocol fixation
| 2007 | Year | 10 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 11 | Month | 01 | Day |
Date analysis concluded
| 2016 | Year | 11 | Month | 01 | Day |
Other
Other related information
We have reported atherosclerotic genetic risk factors of 690 diabetic patients (Yamasaki Y et al. Diabetes Care 29: 2445-2451, 2006). Since then, we have enrolled more patients and the number reached up to 2500. Among them, as a control of study 2, we selected those who have at least 10 years of disease duration, who do not excrete overt proteinuria and whose age and sex are matched with those of case group in study 2.
Management information
Registered date
| 2007 | Year | 11 | Month | 14 | Day |
Last modified on
| 2008 | Year | 12 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001071
