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NCT Number: NCT05365425

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

This is a randomized controlled study to assess the effect of choline fenofibrate compared with policosanol in Korean T2DM patients with asymptomatic atherosclerosis.

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Key information

Conditions

Dyslipidemia Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 2 Dyslipidemias Endocrine System Diseases Glucose Metabolism Disorders Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Choline Fenofibrate

Drug

choline fenofibrate 178.8mg (135mg as fenofibric acid)

Other names: Tgfenon

Policosanol

Drug

policosanol 10mg

Other names: Policosanol 10

Primary outcomes

  1. Carotid intima media thickness

    Time frame: 24 week

    Maximum carotid IMT (mm)

Secondary outcomes

  1. Area of carotid artery plaque

    Time frame: 24 week

    measured by ultrasound

  2. Plaque characteristics

    Time frame: 24 week

    changes of non-calcified plaque volume (mm3)

  3. Glucose homeostasis

    Time frame: 24 week

    changes of HbA1c (%)

  4. Lipid metabolism

    Time frame: 24 week

    TG concentration, HDL-cholesterol concentration

  5. Bioelectrical Impedance Analysis

    Time frame: 24 week

    Body composition of fat mass (kg)

  6. Proteinuria

    Time frame: 24 week

    albumin-to-creatinine ratio (mg/g)

  7. changes of gut microbiota

    Time frame: 24 week

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

Study contacts

Contact information is provided by the study sponsor or research team.

Minji Sohn

CONTACT

[email protected]

Soo Lim

CONTACT

[email protected]

+82-31-787-7035

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Collaborators

  • Daewon Pharmaceutical Co., Ltd.

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
May 9, 2022
Registry last updated
May 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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