UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000024915
Receipt number R000028662
Scientific Title Advanced Preventive Medicine research in lifestyle-related diseases
Date of disclosure of the study information 2016/12/01
Last modified on 2016/11/20 18:44:30

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Basic information

Public title

Advanced Preventive Medicine research in lifestyle-related diseases

Acronym

Advanced Preventive Medicine research in lifestyle-related diseases

Scientific Title

Advanced Preventive Medicine research in lifestyle-related diseases

Scientific Title:Acronym

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

1st name
Middle name
Last name Hiroyuki Nakamura

Organization

Kanazawa University

Division name

Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences

Zip code


Address

13-1 Takaramachi, Kanazawa, Ishikawa, Japan

TEL

076-265-2215

Email

hiro-n@po.incl.ne.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hiromasa Tsujiguchi

Organization

Kanazawa University

Division name

Faculty of Medicine, Institute of Medical, Pharmaceutical and Health Sciences

Zip code


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 or person

Institute

Kanazawa University

Institute

Department

Personal name



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)



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

2016 Year 12 Month 01 Day


Related information

URL releasing protocol


Publication of results

Partially published


Result

URL related to results and publications

http://www.projectship.org/achievement.html

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

Date of protocol fixation

2013 Year 12 Month 01 Day

Date of IRB


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



Other

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028662


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name