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Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
placebo
fenofibrate/omega
fenofibrate
Sponsored by
Gachon University Gil Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia focused on measuring insulin resistance

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

  • moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease

Sites / Locations

  • Gil Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Active Comparator

Active Comparator

Arm Label

placebo

fenofibrate/omega

fenofibrate

Arm Description

placebo

fenofibrate/omega

fenofibrate

Outcomes

Primary Outcome Measures

flow-mediated dilation

Secondary Outcome Measures

insulin resistance

Full Information

First Posted
August 15, 2012
Last Updated
November 1, 2014
Sponsor
Gachon University Gil Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01666041
Brief Title
Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate
Study Type
Interventional

2. Study Status

Record Verification Date
August 2012
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
February 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Gachon University Gil Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators hypothesize that fenofibrate/omega will improve insulin resistance compared with fenofibrate

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia
Keywords
insulin resistance

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
placebo
Arm Title
fenofibrate/omega
Arm Type
Active Comparator
Arm Description
fenofibrate/omega
Arm Title
fenofibrate
Arm Type
Active Comparator
Arm Description
fenofibrate
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Type
Drug
Intervention Name(s)
fenofibrate/omega
Intervention Type
Drug
Intervention Name(s)
fenofibrate
Primary Outcome Measure Information:
Title
flow-mediated dilation
Time Frame
8 weeks of treatment
Secondary Outcome Measure Information:
Title
insulin resistance
Time Frame
8 weeks of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hypertriglyceridemia Exclusion Criteria: moderate or severe hypertension, uncontrolled diabetes (HbA1c > 9%), nephrotic syndrome, hypothyroidism, coronary artery disease, or peripheral vascular disease
Facility Information:
Facility Name
Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of

12. IPD Sharing Statement

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Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

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