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

October 1, 2022 updated by: Soo Lim, Seoul National University Bundang Hospital

Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

56

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tgfenon
Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet
Drug: Choline fenofibrate
choline fenofibrate 178.8mg (135mg as fenofibric acid)
Other Names:
  • Tgfenon
Active Comparator: Policosanol 10
Policosanol 10mg 1 tablet once daily oral administration
Drug: Policosanol
policosanol 10mg
Other Names:
  • Policosanol 10

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Collaborators

Daewon Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

June 1, 2023

Primary Completion (Anticipated)

March 31, 2024

Study Completion (Anticipated)

December 31, 2024

Study Registration Dates

First Submitted

March 16, 2022

First Submitted That Met QC Criteria

May 3, 2022

First Posted (Actual)

May 9, 2022

Study Record Updates

Last Update Posted (Actual)

October 4, 2022

Last Update Submitted That Met QC Criteria

October 1, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-2111-720-003

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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