Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

Detailed Description
-----------------
In patients with type 2 diabetes with atherosclerotic combined dyslipidemia, the effect of choline fenofibrate on the progression of carotid intima media thickness and carotid artery plaque will be evaluated by 3D carotid ultrasound.

Official Title
-----------------
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia

Conditions
-----------------
Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Choline fenofibrate
* Drug: Policosanol


Participation Criteria
=================
Eligibility Criteria
-----------------
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: triglyceride 200 499 mg/dL, HDL-cholesterol male ≤45 mg/dL or female ≤50 mg/dL Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.5 mm Creatinine ≤1.8 mg/dL Exclusion Criteria: Dyslipidemia which requires other therapy: triglyceride ≥500 mg/dL or LDL-cholesterol ≥190 mg/dL Uncontrolled hypertension Severe renal dysfunction GOT/GPT >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 Other antiplatlet medication such as cilostazol, clopidogrel (except aspirin)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tgfenon<br>Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet | Drug: Choline fenofibrate<br>* choline fenofibrate 178.8mg (135mg as fenofibric acid)<br>* Other names: Tgfenon;|
| Active Comparator: Policosanol 10<br>Policosanol 10mg 1 tablet once daily oral administration | Drug: Policosanol<br>* policosanol 10mg<br>* Other names: Policosanol 10;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of carotid artery plaque | measured by 3D ultrasound imaging | 24 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Carotid intima media thickness | Maximum carotid IMT (mm) | 24 week | 
| Coronary artery stenosis | Severity of coronary artery stenosis percent | 24 week | 
| Plaque characteristics | changes of non-calcified plaque volume (mm3) | 24 week | 
| Coronary artery calcium score | 0: No calcification of artery [higher scores implies worsening] | 24 week | 
| Glucose homeostasis | changes of HbA1c (%) | 24 week | 
| Lipid metabolism | TG concentration, HDL-cholesterol concentration | 24 week | 
| Bioelectrical Impedance Analysis | Body composition of fat mass (kg) | 24 week | 
| Proteinuria | albumin-to-creatinine ratio (mg/g) | 24 week | 
| changes of gut microbiota | measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species | 24 week |