search
Back to results

Differential Metabolic Effects of Fenofibrate and Fatty Acid

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fenofibrate, fatty acid, placebo
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 - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

  • Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension

Sites / Locations

  • Gil Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

fenofibrate

fatty acid

Placebo

Arm Description

drug

Outcomes

Primary Outcome Measures

flow-mediated dilation

Secondary Outcome Measures

insulin resistance

Full Information

First Posted
October 28, 2009
Last Updated
May 9, 2011
Sponsor
Gachon University Gil Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01003847
Brief Title
Differential Metabolic Effects of Fenofibrate and Fatty Acid
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

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 and fatty acid may have different metabolic effects in hypertriglyceridemic patients

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
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
fenofibrate
Arm Type
Active Comparator
Arm Title
fatty acid
Arm Type
Active Comparator
Arm Description
drug
Arm Title
Placebo
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
fenofibrate, fatty acid, placebo
Intervention Description
fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment
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
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: hypertriglyceridemia Exclusion Criteria: Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
Facility Information:
Facility Name
Gil Medical Center
City
Incheon
ZIP/Postal Code
405-760
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

Differential Metabolic Effects of Fenofibrate and Fatty Acid

We'll reach out to this number within 24 hrs