UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Advanced Preventive Medicine research in lifestyle-related diseases
Title of the study (Brief title)	Advanced Preventive Medicine research in lifestyle-related diseases
Region	Japan

Condition
Condition	Diabetes, Allergies, Fatty liver, Hypertension, Primary aldosteronism, IgG4-related disease, Osteoporosis, Dementia, Chronic pain
Classification by specialty	Medicine in general Hepato-biliary-pancreatic medicine Cardiology Endocrinology and Metabolism Nephrology Neurology Clinical immunology Orthopedics Adult
Classification by malignancy	Others
Genomic information	YES

Objectives
Narrative objectives1	40 years or older residents are screened by questionnaire, interview, body measurement, urinalysis, blood tests, genes, or ultrasonography. By examining the relations between each data and lifestyle-related diseases such as diabetes, fatty liver, primary aldosteronism, IgG4-related disease, dementia, osteoporosis, and allergy biomarkers for early detection of diseases are searched. Thereby, personalized prophylaxes of lifestyle-related diseases are devised.
Basic objectives2	Others
Basic objectives -Others	Epidemiology, and Molecular epidemiology
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1 Questionnaire Family medical history of dementia, memory impairment, FRAX, SF36, Falling times, Falling place, ECRHS, Rheumatism, Sjogren syndrome, and CES-D 2 Interview MMSE (Mini-mental State Examination),Stiff joint and stiffness in the hand 3 Body measurement Height, Weight, Waist circumference, Lower thigh circumference, Grip, Body constitution, Blood pressure 4 Bone density 5 Body balance 6 Fatty liver 7 Urinalysis Occult blood in urine, Urine protein, Urine glucose, Albumin g/ Cr, Sodium discharge amount (the estimated sodium intake), Creatinine, 8OHDG (oxidative stress), Potassium,Crawl, Lithic nitrogen, Magnesium, Phosphorus, Calcium, Lithic acid, MCP-1 in the urine 8 Blood test RBC, WBC, Plt, Hb, Neutrophil, Acidophil/Eosinophil/Acidophilic leucocyte, Basophil, Monocyte, Mononuclear leucocyte, Lymphocyte, Na, Ca, Cl, Ca, P, BUN, Cr, UA, CRP, AST, ALT, ALP, rGTP, TC, TG, HDL-cho,Hunger blood glucose, Hb-A1c, Blood count, Amylase, Selenoprotein P, LECT2, Carotenoido, Vitamins, Amino acid fractionation, Fatty acid constitution, Insulin, Selenium,Aldosteron/renin, Anti CCP antibody, RF, IgG, IgG4, CH50, ANA, SSA, 25(OH)D, ucOC,Homocystine, IgE antibody, Allergen (Ceder, Cypress, House dust, Orchardgrass, House dust mite), Hormone and protein density in the blood (Testosterone SHBG,Luteinizing hormone (LH), Follicle-stimulating hormone (FSH) and the Estradiol (E2)), Cytokine,(IL6 and TNF-a, IL-12, IL-17, IL-33 and IL-10, Fatty acid fractionation, Oxidized LDL cholesterol, Sensitive CRP ,Comprehensive protein measurement 9 Genomic analysis DNA extraction,Gene expression analysis of PBMC,PAXgene blood test pipe
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	40 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Residents of Shika town, Ishikawa prefecture, Japan
Key exclusion criteria	Using hypotensive drug or drug for diseases described above
Target sample size	10000

Research contact person
Name of lead principal investigator	Hiroyuki Nakamura
Organization	Kanazawa University
Division name	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Address	13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL	076-265-2215
Email	hiro-n@po.incl.ne.jp

Public contact
Name of contact person	Hiromasa Tsujiguchi
Organization	Kanazawa University
Division name	Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences
Address	13-1 Takaramachi, Kanazawa, Ishikawa, Japan
TEL	076-265-2288
Homepage URL	http://www.projectship.org/
Email	t-hiromasa@med.kanazawa-u.ac.jp

Sponsor
Institute	Kanazawa University
Institute
Department

Funding Source
Organization	Ministry of Medicine, Institute of Medical, Pharmaceutical, and Health Sciences
Organization
Division
Category of Funding Organization	Japanese Governmental office
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	2016 Year 12 Month 01 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2013 Year 12 Month 01 Day
Anticipated trial start date	2014 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	Partially published
URL releasing results	http://www.projectship.org/achievement.html
Results
Other related information	Cohort study

Management information
Registered date	2016 Year 11 Month 20 Day
Last modified on	2016 Year 11 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028662