UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010436
Receipt number R000012203
Scientific Title Clinical benefit of measurement of remnant lipoprotein-cholesterol level in type 2 diabetes
Date of disclosure of the study information 2013/04/08
Last modified on 2014/12/16 10:43:53

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Basic information

Public title

Clinical benefit of measurement of remnant lipoprotein-cholesterol level in type 2 diabetes

Acronym

Clinical benefit of RemL-C measurement in Type2 DM

Scientific Title

Clinical benefit of measurement of remnant lipoprotein-cholesterol level in type 2 diabetes

Scientific Title:Acronym

Clinical benefit of RemL-C measurement in Type2 DM

Region

Japan


Condition

Condition

type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

Te aim of the study is to investigate the level of remnant lipoprotein-cholesterol, and its correlation with atherosclerotic markers in patient with type 2 diabetes.

Basic objectives2

Bio-availability

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

Correlation between serum level of RemL-C and other atherosclerotic markers (leukocyte counts, total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride, fasting glucose level, fasting serum insulin level, HbA1c, hs-CRP, mean-IMT, baPWV, TNFalpha, IL-6, adiponectin, sd-LDL-C and hs-TnT).

Key secondary outcomes



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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male and Female

Key inclusion criteria

We will recruited 200 patients with type 2 diabetes who were hospitalized for glycemic control in Kumamoto University Hospital.

Key exclusion criteria

1. Patients with acute/chronic inflammatory disease
2. Patients with severe hepatic disease
3. Patients with fresh cerebrovascular disease
4. Patients with fresh cardiovascular disease
5. Patients with severe respiratory disease, heart disease and arrhythmia

Target sample size

200


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, Chuo, Kumamoto, 860-8556, Japan

TEL

096-373-5169

Email

takeshim@gpo.kumamoto-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takeshi Matsumura

Organization

Faculty of life sciences, Kumamoto University

Division name

Department of Metabolic Medicine

Zip code


Address

1-1-1 Honjo, Chuo, Kumamoto

TEL

096-373-5169

Homepage URL


Email

takeshim@gpo.kumamoto-u.ac.jp


Sponsor or person

Institute

Human Ethics Review Committee of Kumamoto University

Institute

Department

Personal name



Funding Source

Organization

This work was supported by a Grant-in-Aid for Scientific Research from the Japan Society for the Promotion of Science, Japan

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


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

熊本大学医学部附属病院


Other administrative information

Date of disclosure of the study information

2013 Year 04 Month 08 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

2012 Year 09 Month 01 Day

Date of IRB


Anticipated trial start date

2012 Year 09 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information

recruiting


Management information

Registered date

2013 Year 04 Month 07 Day

Last modified on

2014 Year 12 Month 16 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012203


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name