UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005520 |
|---|---|
| Receipt number | R000006545 |
| Scientific Title | Studies on the mutual relationship between hyperuricemia and its associated diseases such as renal dysfunction, hypertension, hyperglycemia, proteinuria, Aciduria, nephrolithiasis, and metabolic syndrome. |
| Date of disclosure of the study information | 2011/04/27 |
| Last modified on | 2011/04/27 18:05:09 |
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Basic information
Public title
Studies on the mutual relationship between hyperuricemia and its associated diseases such as renal dysfunction, hypertension, hyperglycemia, proteinuria, Aciduria, nephrolithiasis, and metabolic syndrome.
Acronym
Studies on the mutual relationship between hyperuricemia and its associated diseases.
Scientific Title
Studies on the mutual relationship between hyperuricemia and its associated diseases such as renal dysfunction, hypertension, hyperglycemia, proteinuria, Aciduria, nephrolithiasis, and metabolic syndrome.
Scientific Title:Acronym
Studies on the mutual relationship between hyperuricemia and its associated diseases.
Region
| Japan |
Condition
Condition
Gout, hyperuricemia
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between hyperuricemia and its associated diseases such as renal dysfunction, hypertension, hyperglycemia, proteinuria, nephrolithiasis, and metabolic syndrome by comparing clinical findings between gout patients and normouricemic subjects.
Basic objectives2
Others
Basic objectives -Others
Large observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
eGFR, Serum creatinine value, CT findings
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
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 79 | years-old | >= |
Gender
Male
Key inclusion criteria
1. Gout patients
Patients who were diagnosed with primary gout according to the criteria of the American College of Rheumatology.
2. Normouricemic individuals as normal control group (Recruited from multiphasic health screening examinees)
Key exclusion criteria
1. Gout patients
Patients whom influence of uric acid lowering medicine are supposed to be left.
Patients 80 years or older.
2. Normouricemic individuals
Those who are taking diuretic drugs or uric acid lowering drugs.
Those who are inappropriate as normal control.
Target sample size
8650
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Toru Shimizu |
Organization
Midorigaoka Hospital
Division name
Gout Division, Dept. of Rheumatology
Zip code
Address
3-13-1 Makami-cho, Takatsuki, Osaka
TEL
072-681-5717
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Midorigaoka Hospital
Division name
Gout Division, Dept. of Rheumatology
Zip code
Address
TEL
Homepage URL
shimizut@gold.ocn.ne.jp
Sponsor or person
Institute
Midorigaoka Hospital
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
| 2011 | Year | 04 | Month | 27 | 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
Completed
Date of protocol fixation
| 2002 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2002 | Year | 01 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objective variables; eGFR, Serum creatinine value, CT findings.
Explanatory variables; Age, Hyperuricemia, Hypertension, Hyperglycemia, Proteinuria, Obesity, CT findings, urine pH.
Management information
Registered date
| 2011 | Year | 04 | Month | 27 | Day |
Last modified on
| 2011 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006545
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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