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

Primary Purpose

Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2

Status
Recruiting
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Choline fenofibrate
Policosanol
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dyslipidemia

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • SNUBHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tgfenon

Policosanol 10

Arm Description

Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet

Policosanol 10mg 1 tablet once daily oral administration

Outcomes

Primary Outcome Measures

Volume of carotid artery plaque
measured by 3D ultrasound imaging

Secondary Outcome Measures

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

Full Information

First Posted
March 16, 2022
Last Updated
October 1, 2022
Sponsor
Seoul National University Bundang Hospital
Collaborators
Daewon Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05365425
Brief Title
Choline Fenofibrate and Carotid Atherosclerosis in Patients With Type 2 Diabetes and Combined Dyslipidemia
Official Title
Effect of Choline Fenofibrate on Carotid Atherosclerosis Estimated by 3D Ultrasound in Patients With Type 2 Diabetes and Combined Dyslipidemia
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
March 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital
Collaborators
Daewon Pharmaceutical Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dyslipidemia, Atherosclerosis, Diabetes Mellitus, Type 2

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
56 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tgfenon
Arm Type
Experimental
Arm Description
Choline fenofibrate (135mg as fenofibric acid) 1 tablet once daily oral administration regardless of diet
Arm Title
Policosanol 10
Arm Type
Active Comparator
Arm Description
Policosanol 10mg 1 tablet once daily oral administration
Intervention Type
Drug
Intervention Name(s)
Choline fenofibrate
Other Intervention Name(s)
Tgfenon
Intervention Description
choline fenofibrate 178.8mg (135mg as fenofibric acid)
Intervention Type
Drug
Intervention Name(s)
Policosanol
Other Intervention Name(s)
Policosanol 10
Intervention Description
policosanol 10mg
Primary Outcome Measure Information:
Title
Volume of carotid artery plaque
Description
measured by 3D ultrasound imaging
Time Frame
24 week
Secondary Outcome Measure Information:
Title
Carotid intima media thickness
Description
Maximum carotid IMT (mm)
Time Frame
24 week
Title
Coronary artery stenosis
Description
Severity of coronary artery stenosis percent
Time Frame
24 week
Title
Plaque characteristics
Description
changes of non-calcified plaque volume (mm3)
Time Frame
24 week
Title
Coronary artery calcium score
Description
0: No calcification of artery [higher scores implies worsening]
Time Frame
24 week
Title
Glucose homeostasis
Description
changes of HbA1c (%)
Time Frame
24 week
Title
Lipid metabolism
Description
TG concentration, HDL-cholesterol concentration
Time Frame
24 week
Title
Bioelectrical Impedance Analysis
Description
Body composition of fat mass (kg)
Time Frame
24 week
Title
Proteinuria
Description
albumin-to-creatinine ratio (mg/g)
Time Frame
24 week
Title
changes of gut microbiota
Description
measured by 16S rRNA or metagenome sequencing, comparing the composition or each phylum/genus/species
Time Frame
24 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Soo Lim
Phone
+82-31-787-7035
Email
limsoo@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Minji Sohn
Email
rainbowmjs@naver.com
Facility Information:
Facility Name
SNUBH
City
Seongnam
State/Province
Gyeonggi
ZIP/Postal Code
13620
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Soo Lim
Phone
01097662706
Email
limsoo@snu.ac.kr

12. IPD Sharing Statement

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

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