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
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
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
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
