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Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles

Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles - Lipoprotein Particles Size test

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000050974
Enrollment
100
Registered
2023-12-31
Start date
2023-06-05
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Examination of the validity of the 2022 guideline for the prevention of arteriosclerotic diseases from the viewpoint of the size of lipoprotein particles

Interventions

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 neces

Sponsors

Saitama Medical University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
TC, TG, HDL-C, LDL-C, lipoprotein size, ability to miniaturize lipoprotein

Secondary

MeasureTime frame
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

Countries

Japan

Contacts

Public ContactIkuo Inoue

Saitama Medical University Department of Endocrinology and Diabetes

i1901018@saitama-med.ac.jp0492761204

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026