UMIN-CTR Clinical Trial

Public title

Study of the Effects of eicosapentaenoic acid on diabetic atherosclerotic lesion

Acronym

E-EPADALE

Scientific Title

Study of the Effects of eicosapentaenoic acid on diabetic atherosclerotic lesion

Scientific Title:Acronym

E-EPADALE

Region

Japan

Condition

Type 2 diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Cardiovascular disease (CVD) is a major cause of death and impairment of quality of life in patients with type 2 diabetes mellitus (T2DM). Therefore, its early detection and rapid intervention is critical in the management of these patients. Since disruption of an atherosclerotic plaque plays a crucial role in the pathogenesis of CVD, such treatment approach that leads to stabilize atherosclerotic plaque would reduce the development of CVD.
Several epidemiological studies have suggested that an increased dietary intake of fish or fish oil is inversely correlated with the onset of cardiovascular disease. The principle components of fish oil are polyunsaturated n-3 fatty acids (n-3 PUFA), such as eicosapentaenoic acid (EPA) or docosahexaenoic acid (DHA). Although the beneficial effects of an increased intake of n-3 PUFA were thought to be due to their anit-thrombotic effect, an anti-inflammatory effect, an antiatherosclerotic effect, a blood pressure (BP) lowering effect, and a triglyceride lowering effect, there are only limited data about the effect of EPA on the tissue characteristics of atherosclerotic plaque in patients with T2DM.
We therefore initiated a 12-month prospective follow-up interventional study to clarify the efficacy and usefulness of EPA in the treatment of atherosclerosis in subjects with T2DM and dyslipidemia. Assessment will be performed by chronologically observing the integrated backscatter (IBS) signal obtained by ultrasound examination of the carotid artery, which is a marker for tissue characteristics of carotid plaque.

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Changes in the calibrated-IBS value measured at the thickest site of the carotid artery during a 12-months treatment period

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

statin + EPA group (Group SE);
Clinical investigators will initiate EPA (1800 mg/day) treatment in those who were already receiving simvastatin (5-20 mg/day) or pravastatin (5-20 mg/day). Treatment will be continued to achieve the target value specified in the dyslipidemia treatment guidelines.

Interventions/Control_2

statin mono-therapy group (Group SM);
Clinical investigators will continue simvastatin (5-20 mg/day) or pravastatin (5-20 mg/day) treatment following the allocation in the statin mono-therapy group. Treatment will be continued to achieve the target value specified in the dyslipidemia treatment guidelines.

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

20

years-old

<=

Age-upper limit

80

years-old

>

Gender

Male and Female

Key inclusion criteria

1) dyslipidemic type 2 diabetic patients treated with pravastatin or simvastatin
2) Aged 20 to 80 years of age at the time of enrollment (regardless of gender)
3) Written consent for participation in the study

Key exclusion criteria

Patients meeting one of the following conditions will be excluded:
1) type 1 and secondary diabetes, 2) severe infectious disease, before or after surgery, and severe trauma, 3) events of myocardial infarction, angina pectoris, cerebral stroke, and cerebral infarction, 4) moderate or severe renal dysfunction (serum creatinine (mg/dL): male, 1.4<; female, 1.2<), 5) severe liver dysfunction (AST: 100 IU/l or higher), 6) moderate or severe heart failure) (NYHA/New York Heart Association stage III or severer), 7) under treatment with an EPA preparation at the time of study initiation, 8) pregnant, lactating, and possibly pregnant women and those planning to become pregnant, 9) patients with bleeding (hemophilia, gastrointestinal ulceration, urinary tract bleeding, hemoptysis, vitreous hemorrhage, etc.), 10) past medical history of hypersensitivity to investigational drugs, 11) judged as ineligible by clinical investigators.

Target sample size

44

Name of lead principal investigator

1st name
Middle name
Last name	Taka-aki Matsuoka

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3743

Email

matsuoka@endmet.med.osaka-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Naoto Katakami

Organization

Osaka University Graduate School of Medicine

Division name

Department of Metabolic Medicine

Zip code

Address

2-2 Yamadaoka, Suita, Osaka

TEL

06-6879-3743

Homepage URL

Email

katakami@endmet.med.osaka-u.ac.jp

Institute

Osaka University Graduate School

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

大阪大学医学部附属病院

Date of disclosure of the study information

2012

Year

04

Month

25

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

Terminated

Date of protocol fixation

2012

Year

01

Month

30

Day

Date of IRB

Anticipated trial start date

2012

Year

02

Month

01

Day

Last follow-up date

2014

Year

11

Month

06

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2012

Year

04

Month

25

Day

Last modified on

2015

Year

04

Month

27

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007665