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

Last updated: April 30, 2024
Sponsor: Seoul National University Bundang Hospital
Overall Status: Active - Recruiting

Phase

4

Condition

Dyslipidemia

Diabetes Mellitus, Type 2

Diabetes Prevention

Treatment

Choline fenofibrate

Policosanol

Clinical Study ID

NCT05365425
B-2111-720-003
  • Ages > 20
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 orfemale ≤50 mg/dL
  • Identified carotid artery plaque: carotid intima-media thickness (cIMT) ≥ 1.0 mm
  • Creatinine ≤1.8 mg/dL

Exclusion

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

Total Participants: 56
Treatment Group(s): 2
Primary Treatment: Choline fenofibrate
Phase: 4
Study Start date:
June 01, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • SNUBH

    Seongnam, Gyeonggi 13620
    Korea, Republic of

    Active - Recruiting

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