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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000015010
Receipt No. R000017458
Scientific Title Examination of non-cholesterol sterols as the biomarkers for insulin resistance and inflammation
Date of disclosure of the study information 2014/09/01
Last modified on 2016/03/01

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Basic information
Public title Examination of non-cholesterol sterols as the biomarkers for insulin resistance and inflammation
Acronym Non-cholesterol sterols as markers for insulin resistance and inflammation
Scientific Title Examination of non-cholesterol sterols as the biomarkers for insulin resistance and inflammation
Scientific Title:Acronym Non-cholesterol sterols as markers for insulin resistance and inflammation
Region
Japan

Condition
Condition type 2 diabetes, normal subject
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There are several risk factors for atherosclerotic diseases. Among them, insulin resistance and inflammation are classified as the residual risk factors for atherosclerotic diseases. In the plasma, non-cholesterol sterols like sitosterol, campesterol, lathosterol and desmosterol exist. In this study, we elcidate the association of the plasma levels of non-cholesterol sterol and the insulin resistance and inflammation.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes First, we measure the levels of several sterols with FPLC using human plasma samples. Then, we will analyze the association of these sterol values with the markers for insulin resistance (HOMA-IR, adiponectin levels, etc) and the markers for inflammation (high sensitive CRP, TNFa, bioactive phospholipids, etc).
Key secondary outcomes

Base
Study type Others,meta-analysis etc

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
65 years-old >
Gender Male and Female
Key inclusion criteria Those who are not taking anti-hyperlipidemic medicine.
Those who are not under insulin therapy.
Key exclusion criteria Those who suffer from critical illness (liver diseases, kidney diseases, heart diseases, malignancies, etc.)
Those who suffer from collagen diseases.
Those who suffered from acute inflammatory diseases during the past 2 weeks.
Those who are pregnant, breast-feeding, or have the probability of pregnancy.
Those whose HbA1c values are more than 7.5%.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuhisa Tsukamoto
Organization Fukushima Medical University, Aizu Medical Center
Division name Department of Metabolism, Diabetes and Nephrology
Zip code
Address 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL 0242-75-2100
Email kazut@fmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazuhisa Tsukamoto
Organization Fukushima Medical University, Aizu Medical Center
Division name Department of Metabolism, Diabetes and Nephrology
Zip code
Address 21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL 0242-75-2100
Homepage URL
Email kazut@fmu.ac.jp

Sponsor
Institute Fukushima Medical University, Aizu Medical Center
Department of Metabolism, Diabetes and Nephrology
Institute
Department

Funding Source
Organization Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Fujitsu Semiconductor Company, Aizuwakamatsu Factory
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
2014 Year 09 Month 01 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 No longer recruiting
Date of protocol fixation
2014 Year 07 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 09 Month 08 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Measurements of the following values will be performed: A. Markers associated with insulin resistance (HOMA-IR, adiponectin, etc.); B. Markers for inflammation (high sensitive CRP, TNFa, etc.); C: plasma levels of sterols. Afterwards, we will examine the association of these markers.

Management information
Registered date
2014 Year 09 Month 01 Day
Last modified on
2016 Year 03 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017458

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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