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

Phase 4

Recruiting

• Conditions: Atherosclerosis; Diabetes Mellitus, Type 2; Dyslipidemia
• Interventions: Drug: Choline fenofibrate; Drug: Policosanol

• Registration Number: NCT05365425
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study First Submitted: 2022-03-16
• Study First Submitted QC: 2022-05-03
• Study First Posted: 2022-05-09
• Study Start: 2023-06-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-30
• Last Update Posted: 2024-05-01
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 56

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) ≥ 1.0 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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tgfenon	Choline fenofibrate	Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet
Policosanol 10	Policosanol	Policosanol 10mg 1 tablet once daily oral administration

Primary Outcome Measures

Name	Time	Method
Carotid intima media thickness	24 week	Maximum carotid IMT (mm)

Secondary Outcome Measures

Name	Time	Method
Plaque characteristics	24 week	changes of non-calcified plaque volume (mm3)
Proteinuria	24 week	albumin-to-creatinine ratio (mg/g)
Bioelectrical Impedance Analysis	24 week	Body composition of fat mass (kg)
Glucose homeostasis	24 week	changes of HbA1c (%)
Area of carotid artery plaque	24 week	measured by ultrasound
Lipid metabolism	24 week	TG concentration, HDL-cholesterol concentration
changes of gut microbiota	24 week	measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species

Trial Locations

Locations (1)

SNUBH; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of