UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005520
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email

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
Email shimizut@gold.ocn.ne.jp

Sponsor
Institute Midorigaoka Hospital
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006545

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.