UMIN-CTR Clinical Trial

Public title

Association of apolipoprotein D with chronic inflammation, diabetes, diabetic complications and atherosclerosis

Acronym

ApoD and diabetic complications

Scientific Title

Association of apolipoprotein D with chronic inflammation, diabetes, diabetic complications and atherosclerosis

Scientific Title:Acronym

ApoD and diabetic complications

Region

Japan

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Chronic inflammation has been known to be associated with the development of several diseases including diabetes, atherosclerosis and cancer. Through the GWAS analysis, we identified apolipoprotein D (apoD) as a factor associated with CRP, which is a marker for chronic inflammation. ApoD, unlike other apolipoproteins, is expressed in the adipose tissue which has a critical role for the development of insulin resistance; thus, it is probable that apoD possesses relationship for the occurrence of diabetes and diabetic complications. In this study, we will cross-sectionally and longitudinally examine the relationship between ApoD and chronic inflammation, diabetes, diabetic complications and atherosclerosis.

Basic objectives2

Bio-availability

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

In the cross-sectional analysis, we will examine the relationship between apoD levels and insulin resistance (HOMA-IR, adiponection levels, etc.), markers for inflammation (CRP, TNFa, etc.), biochemical data, diabetic complication and status of atherosclerotic diseases. Afterwards, patients are followed periodically (one, 3, 6 and 9 years later), and as a longitudinal study, we will examine the influence of apoD and other markers (inflammation, insulin resistance, biochemical data) on the progression of diabetic complications and atherosclerosis.

Key secondary outcomes

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

Age-lower limit

35

years-old

<=

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

Those who are not under insulin therapy.

Key exclusion criteria

Those who suffer from chronic or acute inflammatory diseases (collagen diseases, acute inflammatory diseases during the past 4 weeks, etc.).
Those who suffer from malignant diseases.
Those who are pregnant, breast-feeding, or have the probability of pregnancy.
Those whose HbA1c values are more than 9.0% during the past 3 months.
Those who cannot give us a voluntary informed consent to the study.

Target sample size

400

Name of lead principal investigator

1st name	Kazuhisa
Middle name
Last name	Tsukamoto

Organization

Teikyo University

Division name

Department of Internal Medicine

Zip code

173-8605

Address

2-11-1, Kaga, Itabashi-ku, Tokyo

TEL

03-3964-1211

Email

kazuhisa-tky@umin.ac.jp

Name of contact person

1st name	Kazuhisa
Middle name
Last name	Tsukamoto

Organization

Teikyo University

Division name

Department of Internal Medicine

Zip code

173-8605

Address

2-11-1, Kaga, Itabashi-ku, Tokyo

TEL

03-3964-1211

Homepage URL

Email

kazuhisa-tky@umin.ac.jp

Institute

Teikyo University
Department of Internal Medicine

Institute

Department

Personal name

Organization

Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Co-sponsor

Teikyo University Hospital, Mizonokuchi, Department of Internal Medicine

Name of secondary funder(s)

Organization

IRB, Teikyo University

Address

2-11-1, Kaga, Itabashi-ku, Tokyo

Tel

03-3964-7256

Email

turb-office@teikyo-u.ac.jp

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2017

Year

03

Month

21

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2017

Year

01

Month

10

Day

Date of IRB

2017

Year

03

Month

21

Day

Anticipated trial start date

2017

Year

03

Month

21

Day

Last follow-up date

2029

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

1) Cross-sectional Study:
Measurements of the following values will be performed; A. Apolipoprotein D; B. Markers associated with insulin resistance (HOMA-IR, adiponectin, etc.); C. Markers for inflammation (high sensitive CRP, TNFa, etc.); D: biochemical data (lipid levels, etc.). Afterwards, we will examine the association among these markers and also association of these markers with diabetic complications and atherosclerosis.
2) Longitudinal Study:
Afterwards, data on diabetic complications and atherosclerosis will be obtained periodically (1, 3, 6, 9 years later), and the association of the above mentioned data with these complications will be examined.

Registered date

2017

Year

03

Month

19

Day

Last modified on

2019

Year

03

Month

21

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030557