UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015010 |
|---|---|
| Receipt number | 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 | 2022/03/23 12:27:49 |
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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 | Kazuhisa |
| Middle name | |
| Last name | Tsukamoto |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Department of Metabolism, Diabetes and Nephrology
Zip code
969-3492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL
0242-75-2100
kazuhisatky@gmail.com
Public contact
Name of contact person
| 1st name | Kazuhisa |
| Middle name | |
| Last name | Tsukamoto |
Organization
Fukushima Medical University, Aizu Medical Center
Division name
Department of Metabolism, Diabetes and Nephrology
Zip code
9693492
Address
21-2 Maeda, Tanisawa, Kawahigashi, Aizuwakamatsu City, Fukushima
TEL
0242-75-2100
Homepage URL
kazuhisatky@gmail.com
Sponsor or person
Institute
Fukushima Medical University, Aizu Medical Center
Department of Metabolism, Diabetes and Nephrology
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
None
Address
NA
Tel
NA
NA
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
NA
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1016/j.bbalip.2017.12.004
Number of participants that the trial has enrolled
224
Results
We observed the existence of rather specific negative correlations between the serum sitosterol level and the serum IL-6 and the TNF-a levels in both diabetic subjects and non-diabetic subjects. Multiple regression analyses also revealed that the serum IL-6 and TNF-a levels exhibited strong negative correlations with the serum sitosterol levels.
Results date posted
| 2022 | Year | 03 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2017 | Year | 12 | Month | 06 | Day |
Baseline Characteristics
Diabetic patients (n = 46) and non-diabetic patients (n = 178)
Participant flow
Blood was collected at the time of outpatient visit or medical checkup.
Adverse events
None
Outcome measures
Relationship between plant sterol levels, clinical data and inflammatory cytokine levels
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 07 | Month | 17 | Day |
Date of IRB
| 2014 | Year | 07 | Month | 30 | Day |
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
| 2022 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017458
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/03/23 | 01 研究計画書（別紙様式１） 萌芽研究 140612改訂 黒.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| 2022/03/23 | 非コレステロールステロール症例データformat.xlsx |
| Research case data | |
|---|---|
| Registered date | File name |
| 2022/03/23 | 非コレステロールステロール症例データファイル.xlsx |
Single case data URL
Value
https://center6.umin.ac.jp/ice/17458
