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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013776
Receipt No. 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

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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
Institute Chiba University Hospital, Division of Diabetes, Metabolism and Endocrinology
Institute
Department

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
URL(English) https://upload.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


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