UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Studies on the mutual relationship between hyperuricemia and its associated diseases such as renal dysfunction, hypertension, hyperglycemia, proteinuria, Aciduria, nephrolithiasis, and metabolic syndrome.
Title of the study (Brief title)	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 Orthopedics Urology Radiology Laboratory medicine
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 among gout patients or 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, prevalence of nephrolithiasis
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	8000

Research contact person
Name of lead principal investigator	Toru Shimizu
Organization	Midorigaoka Hospital
Division name	Gout Division, Dept. of Rheumatology
Address	3-13-1 Makami-cho, Takatsuki, Osaka
TEL	072-681-5717
Email

Public contact
Name of contact person
Organization	Midorigaoka Hospital
Division name	Gout Division, Dept. of Rheumatology
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)

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 12 Month 28 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2002 Year 01 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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 12 Month 28 Day
Last modified on	2019 Year 01 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008232