UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013776
Receipt number R000016078
Scientific Title Effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors.
Date of disclosure of the study information 2014/04/21
Last modified on 2018/03/17 23:45:24

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Basic information

Public title

Effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors.

Acronym

Effect of EPA/DHA combination therapy on LDL particle size

Scientific Title

Effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors.

Scientific Title:Acronym

Effect of EPA/DHA combination therapy on LDL particle size

Region

Japan


Condition

Condition

Type 2 diabetes mellitus with hyperlipidemia

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is evaluate the effect of EPA/DHA combination therapy on LDL particle size in patients with hyperlipidemia and type 2 diabetes taking HMG-CoA reductive enzyme inhibitors and DPP-4 inhibitors. It is conducted to the substantial patients from the multi centered participation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

The change of parameters in LDL particle size
(for 12 weeks with administration of EPA/DHA)

Key secondary outcomes

The change of
- LDL particle concentration
- LDL particle number
- Cholesterol and triglyceride concentration, free glycerol concentration
- Other cholesterol and triglyceride particle sizes
- Other cholesterol and triglyceride particle concentration
- Other cholesterol and triglyceride particle number
- Lipoprotein Insulin Resistance Score (LPIR)
- Inflammation Marker (GlycA)
- EPA/AA ratio, DHA/AA ratio
- Lipid profile (LDL-C, HDL-C, TG, etc)
- HbA1c
- Fasting blood glucose
- Safety assessment
(Renal function, Liver function, etc)


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

EPA/DHA formulation
(1) Brand name : Lotriga granulated capsule 2g
(2) Generic name : Omega-3 fatty acids ethyl

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1) Type 2 diabetes mellitus patients, those who received both DPP IV inhibitors and HMG-CoA inhibitors, and have HbA1c level of < 8.0% (NGSP) and LDL-C level of < 120mg/dl.
2) Patients have fasting TG level of >=150mg/dl, those who received diet and exercise therapy more than 12 weeks, and clinically determined to have an additional pharmacotherapy.
3) Patients aged from 20 to 80 years at the baseline
4) Patients provided written informed consent

Key exclusion criteria

Among the patients, those who judged as the criteria below are not eligible for the trial.
1) TG>=1000mg/dl or HDL-C =<30mg/dl
2) Received Fibrates
3) Received Pioglitazone
4) 0mega-3 fatty acids contraindication status (Bleeding: Hemophilia, Peptic ulcer, etc)
5) Hypersensitive history to EPA formulation or EPA/DHA formulation
6) Familial combined hyper low-density lipoproteinaemia
7) Type 1 diabetes mellitus
8) Severe diabetic ketosis, diabetic coma or total coma within 6 months
9) Severe infectious disease, before or after surgery, and sever trauma
10) Moderate renal dysfunction (Serum creatinine (mg/dl): male, 1.5=<; female, 1.3=<)
11) Occurrence of stroke, AMI, and the other severe cardiovascular events that lead patients to be hospitalized within 6 months
12) Concomitant malignant disease
13) Pregnant, lactating, possibly pregnant or planning to become pregnant women
14) Without written informed consent
15) Patients considered as inadequate by the principal investigator

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Masaya Koshizaka

Organization

Chiba University Hospital

Division name

Diabetes, Metabolism and Endocrinology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN

TEL

043-222-7171

Email

overslope@chiba-u.jp


Public contact

Name of contact person

1st name
Middle name
Last name Masaya Koshizaka

Organization

Chiba University Hospital

Division name

Diabetes, Metabolism and Endocrinology

Zip code


Address

1-8-1 Inohana, Chuo-ku, Chiba-shi, Chiba 260-8670, JAPAN

TEL

043-222-7171

Homepage URL


Email

overslope@chiba-u.jp


Sponsor or person

Institute

Chiba University Hospital, Division of Diabetes, Metabolism and Endocrinology

Institute

Department

Personal name



Funding Source

Organization

None

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

2014 Year 04 Month 21 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

https://lipidworld.biomedcentral.com/track/pdf/10.1186/s12944-018-0706-8?site=lipidworld.biomedcentr

Number of participants that the trial has enrolled


Results

Concentrations of total cholesterol (P？<？0.001), LDL-C (P？= 0.003), and triglyceride (P？<？0.001) decreased following n-3 PUFA administration. N-3 PUFAs decreased the size of very low-density lipoprotein (VLDL; P？<？0.001) particles, but did not affect LDL or high-density lipoprotein (HDL) particles. The concentration of large LDL increased, whereas small LDL decreased, causing the large to small LDL ratio to increase significantly (P？=？0.042). Large VLDL and chylomicron concentrations significantly decreased, as did the large to small VLDL ratio (all P？<？0.001). FPG levels unchanged, whereas HbA1c levels slightly increased. LPIR scores improved significantly (P？= 0.001).

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 11 Month 18 Day

Date of IRB


Anticipated trial start date

2013 Year 11 Month 20 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2014 Year 04 Month 21 Day

Last modified on

2018 Year 03 Month 17 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016078


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name