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Atmeg (Atorvastatin and Omega-3 Combination) and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

Sponsor
Seoul National University Bundang Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05365438
Collaborator
Korea United Pharm. Inc. (Industry)
105
Enrollment
3
Arms
31
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This is a randomized controlled study to assess the effect of atorvastatin and omega 3 combination therapy compared with atorvastatin and ezetimibe combination therapy in Korean T2DM patients with asymptomatic atherosclerosis.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of atorvastatin and omega 3 combination on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
105 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Atorvastatin and Omega 3 Combination Therapy on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Anticipated Study Start Date :
Jun 1, 2022
Anticipated Primary Completion Date :
Mar 31, 2024
Anticipated Study Completion Date :
Dec 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Atmeg with Omethyl Cutielet

Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg) Omethyl Cutielet: Omega-3 2000mg (920mg as EPA ethyl ester, 760mg as DHA ethyl ester) once daily

Drug: Omega 3-Atorvastatin
Atmeg 2 capsules with 1 pack of Omethyl cutielet
Other Names:
  • Atmeg-Omethyl cutielet

    		•
    Active Comparator: Atmeg

    Atmeg: 2 capsules daily (1 capsule containes atorvastatin 10 mg and Omega-3 1000 mg)

    Drug: Omega 3-Atorvastatin
    Atmeg 2 capsules
    Other Names:
  • Atmeg

    		•
    Active Comparator: ezetimibe/atorvastatin 10/20

    1 tablet once daily (atorvastatin 20mg with ezetimibe 10mg)

    Drug: Atorvastatin-Ezetimibe
    ezetimibe/atorvastatin 10/20 mg

    Outcome Measures

    Primary Outcome Measures

    1. Volume of carotid artery plaque [24 weeks]

      measured by 3D ultrasound imaging

    Secondary Outcome Measures

    1. Carotid intima media thickness [24 weeks]

    2. Coronary artery stenosis [24 weeks]

      Severity of coronary artery stenosis percent

    3. Plaque characteristics Plaque characteristics Plaque characteristics Plaque characteristics [24 weeks]

      changes of non-calcified plaque volume (mm3)

    4. Coronary artery calcium score [24 weeks]

      0: No calcification of artery [higher scores implies worsening]

    5. Glucose homeostasis [24 weeks]

      changes of HbA1c (%)

    6. Lipid metabolism [24 weeks]

      TG concentration, HDL-cholesterol concentration

    7. Bioelectrical Impedance Analysis [24 weeks]

      Body composition of fat mass (kg)

    8. Proteinuria [24 weeks]

      albumin-to-creatinine ratio (mg/g)

    9. Changes of gut microbiota [24 weeks]

      measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Type 2 diabetes under treatment with HbA1c 6.0-10.0% at screening visit

    • Male or female of 20 years or over

    • Mixed dyslipidemia under moderate-intensity statin: triglyceride ≥200 mg/dL, HDL-cholesterol ≤50 mg/dL, LDL-cholesterol ≥100 mg/dL

    • moderate-intensity statin: atorvastatin 10-20mg, rosuvastatin 5mg, simvastatin 20-40mg, pravastatin 40-80mg, lovastatin 40mg, fluvastatin XL 80mg, fluvastatin 40mg bid, pitavastatin 2-4mg

    • Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.5 mm

    • Asymptomatic patients without history of angina, myocardial infarction, or cerebral infarction

    • Creatinine ≤1.8 mg/dL

    Exclusion Criteria:

    • Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL

    • Uncontrolled hypertension: SBP >180 mmHg or DBP >110 mmHg

    • Severe renal dysfunction: eGFR <30 mL/min/1.73m2

    • AST/ALT >120/120 or chronic liver disease

    • Pregnant or childbearing woman who does not have enough contraception

    • Changes of medication related to chronic diseases (diabetes, hypertension, dyslipidemia, etc.) within 3 months

    • Usage of dyslipidemia therapy other than statin

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Seoul National University Bundang Hospital
    • Korea United Pharm. Inc.

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Soo Lim, Professor, Seoul National University Bundang Hospital
    ClinicalTrials.gov Identifier:
    NCT05365438
    Other Study ID Numbers:
    • B-2111-720-004
    First Posted:
    May 9, 2022
    Last Update Posted:
    May 9, 2022
    Last Verified:
    May 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Carotid Artery Diseases
    Atherosclerosis
    Diabetes Mellitus
    Diabetes Mellitus, Type 2
    Dyslipidemias
    Atorvastatin
    Ezetimibe

    Study Results

    No Results Posted as of May 9, 2022