UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004946 |
|---|---|
| Receipt number | 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 09:31:22 |
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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
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
Sponsor or person
Institute
Department of Metabolic Medicine, Faculty of life sciences, Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005886
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
