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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000004946
Receipt No. R000005886
Scientific Title Serum levels of Cholesterol synthesis/absorption markers in subjects of various diseases.
Date of disclosure of the study information 2011/01/25
Last modified on 2011/11/01

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Basic information
Public title Serum levels of Cholesterol synthesis/absorption markers in subjects of various diseases.
Acronym Study of cholesterol synthesis/absorption markers
Scientific Title Serum levels of Cholesterol synthesis/absorption markers in subjects of various diseases.
Scientific Title:Acronym Study of cholesterol synthesis/absorption markers
Region
Japan

Condition
Condition Normal subjects, Diabetes, Hyperlipidemia, Essential hypertension, Metabolic syndrome
Classification by specialty
Endocrinology and Metabolism Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Te aim of the study is to investigate the level of cholesterol synthesis/absorption markers in patient with diabetes, hyperlipidemia, hypertension or metabolic syndrome compared to the normal subjects.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes 1: Calculation of mean value of cholesterol synthesis/absorption markers.
2: Comparison of serum level of cholesterol synthesis/absorption markers between normal subjects and patients with diabetes, hyperlipidemia, hypertension or metabolic syndrome.
Key secondary outcomes Comparison between cholesterol synthesis/absorption markers and TC, HDL-C, LDL-C, TG, FBG or HbA1.

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
25 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria We enroll all subjects who visit to our hospital or Sugimura hospital.
Number of normal subject:400
Number of Diabetic patients:50
Number of patients with hyperlipidemia:50
Number of patients with hypertension:50
Number of patients with metabolic syndrome: 50
Key exclusion criteria 1.Subjects with inflammation
2.Subjects with fresh cerebrovascular diseases
3.Subjects with hepatic disorder without fatty liver
4.Subjects with severe respiratory disease or severe heart failure
5.Subjects with alcoholicsm or medicinal intoxication
6.Subjects with psychosis
7.Subjects who doctors judge as unfitness
Target sample size 600

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Eiichi Araki
Organization Faculty of life sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address 1-1-1 Honjo, Kumamoto, 860-8556, Japan
TEL 096-373-5169
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Faculty of life sciences, Kumamoto University
Division name Department of Metabolic Medicine
Zip code
Address
TEL 096-373-5169
Homepage URL
Email

Sponsor
Institute Department of Metabolic Medicine, Faculty of life sciences, Kumamoto University
Institute
Department

Funding Source
Organization Department of Metabolic Medicine, Faculty of life sciences, Kumamoto University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Sugimura Hospital
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 熊本大学医学部附属病院(熊本県)、杉村病院(熊本県)

Other administrative information
Date of disclosure of the study information
2011 Year 01 Month 25 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 Open public recruiting
Date of protocol fixation
2010 Year 10 Month 18 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
2012 Year 10 Month 01 Day
Date of closure to data entry
2013 Year 04 Month 01 Day
Date trial data considered complete
2013 Year 04 Month 01 Day
Date analysis concluded
2013 Year 10 Month 01 Day

Other
Other related information Main factor in the study:
Measurement of serum cholesterol synthesis/absorption marker.

Sampling: random

Management information
Registered date
2011 Year 01 Month 25 Day
Last modified on
2011 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005886

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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