UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000011206
Receipt number R000013134
Scientific Title Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Date of disclosure of the study information 2013/07/22
Last modified on 2021/10/05 08:25:32

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Basic information

Public title

Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia

Acronym

Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia

Scientific Title

Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia

Scientific Title:Acronym

Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia

Region

Japan


Condition

Condition

Hypertriglyceridemia with type 2 diabetes

Classification by specialty

Medicine in general Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To clarify the effect of combination therapy of EPA and DHA on arterial stiffness as well as on lipid metabolic factors in type 2 diabetic patients with hypertriglyceridemia

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase

Not applicable


Assessment

Primary outcomes

A change in CAVI(cardio-ankle vascular index)

Key secondary outcomes

Changes in lipid metabolic parameters (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, apoprotein, LPL mass)


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

Switch from Epadel(1800mg/day) to rotoriga (2g/day) for 3 months.
If the triglyceride level in the blood does not meet the management standards, will be increased to 4g/day from 2g/day the dose of rotoriga.

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

30 years-old <=

Age-upper limit

80 years-old >

Gender

Male and Female

Key inclusion criteria

Outpatients in Center of Diabetes, Endocrine and Metabolism, Toho University Sakura Medical Center with type 2 diabetes and hypertriglyceridemia, taking 1800mg/day of epadel.

Key exclusion criteria

Severe hypertriglyceridemia (TG>1000mg/dl)
Familial hypercholesterolemia
Patients with allergy to DHA

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Takashi Yamaguchi

Organization

Toho University Sakura Medical Cneter

Division name

Center of Diabetes, Endocrine and Metabolism

Zip code


Address

564-1, Shimoshizu, Sakura-City, Chiba, Japan

TEL

+81-43-462-8811

Email

takashi_schecter@sakura.med.toho-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Takashi Yamaguchi

Organization

Toho University Sakura Medical Cneter

Division name

Center of Diabetes, Endocrine and Metabolism

Zip code


Address

564-1, Shimoshizu, Sakura-City, Chiba, Japan

TEL

+81-43-462-8811

Homepage URL


Email

takashi_schecter@sakura.med.toho-u.ac.jp


Sponsor or person

Institute

Toho University Sakura Medical Center

Institute

Department

Personal name



Funding Source

Organization

Nothing

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



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



Other administrative information

Date of disclosure of the study information

2013 Year 07 Month 22 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

Completed

Date of protocol fixation

2013 Year 04 Month 01 Day

Date of IRB

2013 Year 06 Month 30 Day

Anticipated trial start date

2013 Year 07 Month 22 Day

Last follow-up date

2015 Year 01 Month 21 Day

Date of closure to data entry

2015 Year 04 Month 22 Day

Date trial data considered complete

2015 Year 05 Month 22 Day

Date analysis concluded

2015 Year 07 Month 22 Day


Other

Other related information



Management information

Registered date

2013 Year 07 Month 17 Day

Last modified on

2021 Year 10 Month 05 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013134


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name