UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016676 |
|---|---|
| Receipt number | R000019353 |
| Scientific Title | Clinical study on the changes in the vascular endothelial function by the intervention for hypertriglyceridemia in patients with type 2 diabetes treated with statin. |
| Date of disclosure of the study information | 2015/03/03 |
| Last modified on | 2019/09/04 10:05:48 |
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Basic information
Public title
Clinical study on the changes in the vascular endothelial function by the intervention for hypertriglyceridemia in patients with type 2 diabetes treated with statin.
Acronym
Interventional study on type2 diabetes with hypertriglyceridemia.
Scientific Title
Clinical study on the changes in the vascular endothelial function by the intervention for hypertriglyceridemia in patients with type 2 diabetes treated with statin.
Scientific Title:Acronym
Interventional study on type2 diabetes with hypertriglyceridemia.
Region
| Japan |
Condition
Condition
Type 2 diabetes patients with hypertriglyceridemia
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In type 2 diabetic patients, it is well known that treatment of hyper-LDL cholesterolemia is very important. However, Sufficient consideration has not been paid for the treatment of hypertriglyceridemia.
Subjects are the patients with type2 diabetes and hypertriglyceridemia showing normal LDL cholesterole level after treatment with statin. All patients are randomly assigned to open-label treatment with either statin or ezetimib/fenofibrate.
The purpose of this study is to investigate the effect of the treatment for hypertriglyceridemia on the changes in the lipid profile and vascular endothelial function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
We compare the lipoprotein profile and FMD(flow mediated dilation) between the two groups(Statin group and Ezetimibe/fenofibrate combination group). we compare also changes in postprandial hypertriglyceridemia.
Key secondary outcomes
Before and after Cookies meal test, relation between lipid parameters(total cholesterol, triglycerides, HDL, LDL, LPL, apoprotein) and FMD.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The continued treatment with statin, and cookies meal test is performed to evaluate postprandial hypertriglyceridemia.
Interventions/Control_2
It's changed to treatment with ezetimib/fenofibrate from treatment with statin, and cookies meal test performed to evaluate postprandial hypertriglyceridemia.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
LDL <=120 mg/dl
TG >=120 mg/dl
HbA1c <=8.0%
Key exclusion criteria
HbA1c > 8.0%.
Patients with severe liver dysfunction.
Patients with history of hypersensitivity to study drugs.
Serum creatinine >= 2.5 mg/dl.
Patients with secondary properties and drug-induced lipid abnormalities.
Patients with familial hypercholesterolemia.
Pregnancy example.
Patients with history of coronary artery disease.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiko |
| Middle name | |
| Last name | NIshio |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Diabetes and Endocrinology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-6478
info@kadai-tounai.com
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Shinnakasu |
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Division name
Department of Diabetes and Endocrinology
Zip code
890-8520
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
TEL
099-275-6478
Homepage URL
atushi312@yahoo.co.jp
Sponsor or person
Institute
Kagoshima University Graduate School of Medical and Dental Sciences
Institute
Department
Personal name
Funding Source
Organization
Kagoshima University Graduate School of Medical and Dental Sciences
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Bayer
Name of secondary funder(s)
Immuno-Biological Laboratory
IRB Contact (For public release)
Organization
Kagoshima University Hospital Clinical Research Center
Address
8-35-1 Sakuragaoka, Kagoshima, Japan
Tel
099-275-5553
info@kadai-tounai.com
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
| 2015 | Year | 03 | Month | 03 | 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
Open public recruiting
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2015 | Year | 01 | Month | 14 | Day |
Anticipated trial start date
| 2015 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 03 | Month | 02 | Day |
Last modified on
| 2019 | Year | 09 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019353
