UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037710 |
|---|---|
| Receipt number | R000043011 |
| Scientific Title | The significance of Hypertriglyceridemia in life-style diseases |
| Date of disclosure of the study information | 2019/08/17 |
| Last modified on | 2023/08/20 11:15:58 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The significance of Hypertriglyceridemia in life-style diseases
Acronym
TG-rich study
Scientific Title
The significance of Hypertriglyceridemia in life-style diseases
Scientific Title:Acronym
TG-rich study
Region
| Japan |
Condition
Condition
Metabolic syndrome, obesity, diabetes, hypertension, chronic kidney disease (CKD)
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
Diagnosis and classification of dyslipidemia associated with various life-style diseases and exploratory research for the elucidation of molecular mechanism for the progression of atherosclerosis.
Basic objectives2
Others
Basic objectives -Others
Identification of disease mechanism for the development of dyslipidemia and atherosclerosis.
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Diagnosis and classification of dyslipidemia.
2. Identification of mutations for the known responsible genes for the development of dyslipidemia such as LPL. APOC2, APOC3, APOA5, LMF1, GPIHBP1, GCKR, CREB3L3, GPD1.
(Since the current study is cross-sectional clinical study, there is no observation period.)
Key secondary outcomes
1. Measurement of HMGB1, HRG, mir-221/222, mir-335, mir-342 in serum and plasma samples.
2. Identification of unknown causal genes for development of dyslipidemia.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Gene | Other |
Interventions/Control_1
Measurement of MGB1, HRG, microRNAs (mir-221/222, mir-335, mir-342) in serum and plasma samples, and identification of mutations in dyslipidemia-related known genes such as LPL. APOC2, APOC3, APOA5, LMF1, GPIHBP1, GCKR, CREB3L3, GPD1, and other unknown genes.
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
The patients with metabolic syndrome, obesity, diabetes, hypertension and chronic kidney disease (CKD), who agree the paticipation in the investigation. The patients will be enrolled regardless of age, gender, out-patient and in-patient.
Key exclusion criteria
The patients who are judged as inappropriate for the study and who disagree the enrollment.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Wada |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7232
junwada@okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Kurooka |
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name
Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Zip code
700-8558
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
TEL
086-235-7235
Homepage URL
shiropanda34@gmail.com
Sponsor or person
Institute
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Nephrology, Rheumatology, Endocrinology and Metabolism
Institute
Department
Personal name
Funding Source
Organization
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences, Department of Nephrology, Rheumatology, Endocrinology and Metabolism
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
Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address
2-5-1 Shikata-cho, Kita-ku, Okayama 700-8558, Japan
Tel
086-235-6938
mae6605@adm.okayama-u.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
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 08 | Month | 17 | 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
| 2019 | Year | 07 | Month | 05 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 05 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 03 | 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
| 2019 | Year | 08 | Month | 17 | Day |
Last modified on
| 2023 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043011
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
