UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028860 |
|---|---|
| Receipt number | R000033033 |
| Scientific Title | The effects of dietary therapy on patients with hypertriglyceridemia |
| Date of disclosure of the study information | 2017/08/28 |
| Last modified on | 2022/09/01 09:26:57 |
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Basic information
Public title
The effects of dietary therapy on patients with hypertriglyceridemia
Acronym
The effects of dietary therapy on patients with hypertriglyceridemia
Scientific Title
The effects of dietary therapy on patients with hypertriglyceridemia
Scientific Title:Acronym
The effects of dietary therapy on patients with hypertriglyceridemia
Region
| Japan |
Condition
Condition
patients with hypertriglyceridemia
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess the effectiveness of long-term dietary therapy for hypertriglyceridemia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Serum triglyceride level(12 months from the start of nutritional guidance)
Key secondary outcomes
Body weight
Serum fatty acid level
Serum small dense LDL level
Serum HDL cholesterol level
Energy and carbohydrate intake
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with serum triglyceride levels greater than 150 mg/dl
Key exclusion criteria
Patients who are undergoing treatment for cancer patients and renal or hepatic dysfunction.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
The University of Shizuoka
Division name
Graduate School of Integrated Pharmaceutical and Nutritional Sciences
Zip code
4228526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5511
arai@u-shizuoka-ken.ac.jp
Public contact
Name of contact person
| 1st name | Hidekazu |
| Middle name | |
| Last name | Arai |
Organization
The University of Shizuoka
Division name
Graduate School of Integrated Pharmaceutical and Nutritional Sciences
Zip code
4228526
Address
52-1 Yada, Suruga-ku, Shizuoka
TEL
054-264-5511
Homepage URL
arai@u-shizuoka-ken.ac.jp
Sponsor or person
Institute
The University of Shizuoka
Institute
Department
Personal name
Funding Source
Organization
The University of Shizuoka
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of the University of Shizuoka
Address
52-1 Yada, Suruga-ku, Shizuoka
Tel
054-264-5103
tyous10@u-shizuoka-ken.ac.jp
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
浅井内科医院（静岡県）
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 08 | Month | 28 | 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
Completed
Date of protocol fixation
| 2013 | Year | 03 | Month | 11 | Day |
Date of IRB
| 2013 | Year | 03 | Month | 29 | Day |
Anticipated trial start date
| 2013 | Year | 03 | Month | 29 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
12 months observation test
Management information
Registered date
| 2017 | Year | 08 | Month | 28 | Day |
Last modified on
| 2022 | Year | 09 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033033
