UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000050974 |
|---|---|
| Receipt number | R000058100 |
| Scientific Title | Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles |
| Date of disclosure of the study information | 2023/12/31 |
| Last modified on | 2023/05/27 13:26:32 |
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Basic information
Public title
Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles
Acronym
Lipoprotein Particles Size test
Scientific Title
Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles
Scientific Title:Acronym
Lipoprotein Particles Size test
Region
| Japan |
Condition
Condition
Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The density gradient electrophoresis (GGE) and nuclear magnetic resonance (NMR) methods widely established overseas to determine the lipoprotein size. And we stablished that by polyacrylamide gel electrophoresis (PAGE) method (Gaussian fitting method). Moreover, we compared the lipoprotein size with the lipoprotein size measured by the particle counting (PM) method.The purpose of this study is to examine the validity of the 2022 guideline for the prevention of arteriosclerotic diseases in terms of the size of lipoprotein particles.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
TC, TG, HDL-C, LDL-C, lipoprotein size, ability to miniaturize lipoprotein
Key secondary outcomes
apoA-I, apoE, apoB, creatinine, BUN, urinalysis, AST, ALT, CK, fasting blood glucose (diabetic cases), HbA1c (diabetic cases), apoE phenotype, blood pressure, weight, physical findings including interview, electrocardiogram, coronary artery computed tomography
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
A regular dose of rosuvastatin or atorvastatin is administered, blood tests are performed monthly or every few months at the outpatient department of our department, the dose is adjusted, and if necessary, the PCSK-9 inhibitor and evolocumab are also used.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Outpatients of Saitama Medical University who have agreed to participate in this study and treatment according to the 2022 Arteriosclerotic Disease Prevention Guidelines, those who meet the following conditions.
1.Patients with 100 mg/dL or more in case of diabetes, peripheral arterial disease, microangiopathy (retinopathy, nephropathy, neuropathy), or smoking
2.Patients with diabetes not accompanied by 1. above 120 mg/dL
3.Patients with an LDL-C level of 70mg/dl or higher in the secondary prevention of arteriosclerotic disease prevention guidelines
Key exclusion criteria
1) Patients receiving insulin
2) Patients receiving glucagon-like peptide 1 (GLP-1) receptor agonists
3) Male, serum Cr over 3.0 mg/dL, female, serum Cr over 2.5 mg/dL
4) Fasting triglyceride (TG) over 400mg/dL
5) HbA1c changed by 3% or more within 2 months
6) Severe ketosis, diabetic coma or precoma, peripheral artery disease, abdominal aortic aneurysm, carotid artery occlusion >50%, carotid endarterectomy, carotid artery stenting, renal artery stenosis, renal artery stenting a case with
7) Patients with severe infections and severe trauma before and after surgery
8) Women who are pregnant or breastfeeding
9) Women of childbearing potential without effective contraceptive methods
10) Patients judged by the investigator and physician to be inadequate
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Ikuo |
| Middle name | |
| Last name | Inoue |
Organization
Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
350-0495
Address
38 Morohongo, Moroyama Town, Iruma District, Saitama Prefecture
TEL
0492761204
i1901018@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | Ikuo |
| Middle name | |
| Last name | Inoue |
Organization
Saitama Medical University
Division name
Department of Endocrinology and Diabetes
Zip code
350-0495
Address
38 Morohongo, Moroyama Town, Iruma District, Saitama Prefecture
TEL
0492761204
Homepage URL
i1901018@saitama-med.ac.jp
Sponsor or person
Institute
Saitama Medical University
Institute
Department
Personal name
Ikuo Inoue
Funding Source
Organization
Saitama Medical University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Saitama Medical University Hospital IRB
Address
Saitama Med Univ Diabet & Endocrinol 38 Morohongo Saitama 350-0495 JAPAN Saitama Med Univ Diabet & Endocrinol 38 Morohongo Saitama
Tel
0492761204
hirb@saitama-med.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
| 2023 | Year | 12 | Month | 31 | 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
| 2023 | Year | 06 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2023 | Year | 06 | Month | 05 | Day |
Last follow-up date
| 2027 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2029 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2023 | Year | 05 | Month | 02 | Day |
Last modified on
| 2023 | Year | 05 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058100
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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