UMIN-CTR Clinical Trial

Public title

The effect of eicosapentaenoic acid on insulin sensitivity in patients with type2 diabetes mellitus and dyslipidemia: a randomized cross-over clinical trial.

Acronym

The effect of EPA on insulin sensitivity

Scientific Title

The effect of eicosapentaenoic acid on insulin sensitivity in patients with type2 diabetes mellitus and dyslipidemia: a randomized cross-over clinical trial.

Scientific Title:Acronym

The effect of EPA on insulin sensitivity

Region

Japan

Condition

Type2 diabetes and dyslipidemia

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate efficacy and sefety of EPA in insulin sensitivity.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Change in hepatokine

Key secondary outcomes

1. Change in insulin sensitivity assessed by the glucose clamp technique
2. Blood glucose control (FPG, IRI, HbA1c)
3. Change in lipid metabolism (TC, HDL-C, TG, EPA/AA ratio)
4. Change in physical findings by change of body weight, adipose mass, basal metabolism and waist circumference
5. Change in biochemical finding
6. Adverse events
7. Change in fecal metabolome

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

oral EPA administration for 3 months then ceasing EPA for 3 months

Interventions/Control_2

follow up for 3 months then starting oral EPA administration

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

Not applicable

Gender

Male and Female

Key inclusion criteria

Type2 diabetes with dyslipidemia (TG>= 150 mg/dL) within 8 weeks before entry

Key exclusion criteria

1. Patients who have history of serious hypersensitivity to EPA.
2. Patients with diabetic ketoacidosis.
3. Patients who have history of severe hypoglycemia with coma or loss of consciousness.
4. Patients with serious infection or severe traumatic injury.
5. Patients who had EPA medication within 8 weeks before entry.
6. Patients with poor glysemic control and identified inappropriate for this study by the physicians in charge.
7. Patients with peritonial dialysis or hemodialysis or severe renal failure like CCR < 30ml/min, sCR <2.5mg/dL for male, or <2.0mg/dL for female.
8. Patients with unstable hypertension with medication like systolic blood pressure above 160 mmHg or diastolic blood pressure above 100mmHg.
9. Patients with severe heart failure like NYHA III or IV, unstable angina, history of myocardial infarction within 1 year.
10. Patients with proliferative retinopathy (excluding old proliferative retinopathy without necessary of intervention) and patients with maculopathy with necessary of intervention
11. Patients who have history of malignancy, except for patients who have history of cured basal cell tumor by appropriate treatment or uterocervical carcinoma in situ or malignancy more than 1 year before and also have no reappearance.
12. Patients with severe complication and identified inappropriate patients for this study by the physicians in charge.
13. The pregnant women or women having possibilities of being pregnant and the women with breast-feeding.
14. Other patients who are identified inappropriate patients for this study by the physicians in charge.

Target sample size

20

Name of lead principal investigator

1st name
Middle name
Last name	Toshinari Takamura

Organization

Kanazawa university

Division name

Department of Disease Control and Homeostasis

Zip code

Address

13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan

TEL

076-265-2234

Email

ttakamura@m-kanazawa.jp

Name of contact person

1st name
Middle name
Last name	Toshinari Takamura

Organization

Kanazawa university

Division name

Department of Disease Control and Homeostasis

Zip code

Address

13-1, Takara-cho, Kanazawa-shi, Kanazawa, 920-8641 Japan

TEL

076-265-2234

Homepage URL

Email

ttakamura@m-kanazawa.jp

Institute

Kanazawa university
Department of Disease Control and Homeostasis

Institute

Department

Personal name

Organization

Kanazawa university
Department of Disease Control and Homeostasis

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

Date of disclosure of the study information

2014

Year

11

Month

12

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

Completed

Date of protocol fixation

2014

Year

11

Month

05

Day

Date of IRB

Anticipated trial start date

2014

Year

11

Month

10

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

11

Month

12

Day

Last modified on

2018

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018139