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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000011206
Receipt No. R000013134
Scientific Title Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Date of disclosure of the study information 2013/07/22
Last modified on 2014/01/20

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Basic information
Public title Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Acronym Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Scientific Title Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Scientific Title:Acronym Effect of combination therapy of EPA and DHA on arterial stiffness in type 2 diabetic patients with hypertriglyceridemia
Region
Japan

Condition
Condition Hypertriglyceridemia with type 2 diabetes
Classification by specialty
Medicine in general Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To clarify the effect of combination therapy of EPA and DHA on arterial stiffness as well as on lipid metabolic factors in type 2 diabetic patients with hypertriglyceridemia
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes A change in CAVI(cardio-ankle vascular index)
Key secondary outcomes Changes in lipid metabolic parameters (total cholesterol, triglyceride, HDL-cholesterol, LDL-cholesterol, apoprotein, LPL mass)

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 Switch from Epadel(1800mg/day) to rotoriga (2g/day) for 3 months.
If the triglyceride level in the blood does not meet the management standards, will be increased to 4g/day from 2g/day the dose of rotoriga.
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
30 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria Outpatients in Center of Diabetes, Endocrine and Metabolism, Toho University Sakura Medical Center with type 2 diabetes and hypertriglyceridemia, taking 1800mg/day of epadel.
Key exclusion criteria Severe hypertriglyceridemia (TG>1000mg/dl)
Familial hypercholesterolemia
Patients with allergy to DHA
Target sample size 50

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takashi Yamaguchi
Organization Toho University Sakura Medical Cneter
Division name Center of Diabetes, Endocrine and Metabolism
Zip code
Address 564-1, Shimoshizu, Sakura-City, Chiba, Japan
TEL +81-43-462-8811
Email takashi_schecter@sakura.med.toho-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takashi Yamaguchi
Organization Toho University Sakura Medical Cneter
Division name Center of Diabetes, Endocrine and Metabolism
Zip code
Address 564-1, Shimoshizu, Sakura-City, Chiba, Japan
TEL +81-43-462-8811
Homepage URL
Email takashi_schecter@sakura.med.toho-u.ac.jp

Sponsor
Institute Toho University Sakura Medical Center
Institute
Department

Funding Source
Organization Nothing
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
2013 Year 07 Month 22 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2013 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 22 Day
Last follow-up date
2015 Year 01 Month 21 Day
Date of closure to data entry
2015 Year 04 Month 22 Day
Date trial data considered complete
2015 Year 05 Month 22 Day
Date analysis concluded
2015 Year 07 Month 22 Day

Other
Other related information

Management information
Registered date
2013 Year 07 Month 17 Day
Last modified on
2014 Year 01 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013134

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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