| Trial ID: | L6054 |
| Source ID: | NCT05365438
|
| Associated Drug: |
Omega 3-Atorvastatin
|
| Title: |
Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Dyslipidemias|Atherosclerosis|Diabetes Mellitus, Type 2
|
| Interventions: |
DRUG: Omega 3-Atorvastatin|DRUG: Omega 3-Atorvastatin|DRUG: Atorvastatin-Ezetimibe
|
| Outcome Measures: |
Primary: Carotid intima media thickness, maximum carotid IMT (mm), 24 weeks | Secondary: Area of carotid artery plaque, measured by ultrasound, 24 weeks|Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics, changes of non-calcified plaque volume (mm3), 24 weeks|Glucose homeostasis, changes of HbA1c (%), 24 weeks|Lipid metabolism, TG concentration, HDL-cholesterol concentration, 24 weeks|Bioelectrical Impedance Analysis, Body composition of fat mass (kg), 24 weeks|Proteinuria, albumin-to-creatinine ratio (mg/g), 24 weeks|Changes of gut microbiota, measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species, 24 weeks
|
| Sponsor/Collaborators: |
Sponsor: Seoul National University Bundang Hospital | Collaborators: Korea United Pharm. Inc.
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
PHASE4
|
| Enrollment: |
105
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
|
| Start Date: |
2022-10-01
|
| Completion Date: |
2026-12-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-05-01
|
| Locations: |
SNUBH, Seongnam, Gyeonggi, 13620, Korea, Republic of
|
| URL: |
https://clinicaltrials.gov/show/NCT05365438
|
