UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011758
Receipt number R000013751
Scientific Title Human in vivo kinetic studies using stable isitopr
Date of disclosure of the study information 2013/10/01
Last modified on 2021/09/19 11:04:23

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Basic information

Public title

Human in vivo kinetic studies using stable isitopr

Acronym

tracer studies using stable isotope

Scientific Title

Human in vivo kinetic studies using stable isitopr

Scientific Title:Acronym

tracer studies using stable isotope

Region

Japan


Condition

Condition

dyslipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

to clarify apoprotein, triglyceride, and glucose metabolism in humans

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Others

Trial characteristics_2

Explanatory

Developmental phase

Phase IV


Assessment

Primary outcomes

metabolic parameters

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

administration of lipid-lowering agents

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

70 years-old >=

Gender

Male and Female

Key inclusion criteria

Dyslipidemic patients fulfilling at least one of the following criteria
1) LDL-C>140mg/dl
2) TG>150mg/dl
3) HDL-C<40mg/dl

Key exclusion criteria

secondary hyperlipidemia

Target sample size

30


Research contact person

Name of lead principal investigator

1st name Katsunori
Middle name
Last name Ikewaki

Organization

National Defense Medical College

Division name

Division of Neurology, Anti-aging, and Vascular Medicine

Zip code

359-8513

Address

3-2 Namiki, Tokorozawa, Japan

TEL

04-2995-1211

Email

kikewaki@hotmail.com


Public contact

Name of contact person

1st name Katsunori
Middle name
Last name Ikewaki

Organization

National Defense Medical College

Division name

Division of Neurology, Anti-aging, and Vascular Medicine

Zip code

359-8513

Address

3-2 Namikim Tokorozawa, Japan

TEL

04-2995-1211

Homepage URL


Email

kikewaki@hotmail.com


Sponsor or person

Institute

National Defense Medical College

Institute

Department

Personal name



Funding Source

Organization

Foundation of Promotion of Defense Medicine

Organization

Division

Category of Funding Organization

Non profit foundation

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

National Defense Mwedical College

Address

3-2 Namiki Tokorozawa

Tel

04-2995-1211

Email

katsunorike@ndmc.ac.jp


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

防衛医科大学校


Other administrative information

Date of disclosure of the study information

2013 Year 10 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

6

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

Completed

Date of protocol fixation

2013 Year 10 Month 01 Day

Date of IRB

2012 Year 02 Month 16 Day

Anticipated trial start date

2013 Year 10 Month 01 Day

Last follow-up date

2021 Year 03 Month 31 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2013 Year 09 Month 13 Day

Last modified on

2021 Year 09 Month 19 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013751


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name