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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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

Email

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


Email

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

Email

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