Differential Metabolic Effects of Fenofibrate and Fatty Acid

May 9, 2011 updated by: Gachon University Gil Medical Center
The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

150

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

23 years to 73 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

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

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
Active Comparator: Placebo
Drug: fenofibrate, fatty acid, placebo
fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment
Active Comparator: fenofibrate
Drug: fenofibrate, fatty acid, placebo
fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment
Active Comparator: fatty acid
drug
Drug: fenofibrate, fatty acid, placebo
fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
flow-mediated dilation
Time Frame: 8 weeks of treatment
8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
insulin resistance
Time Frame: 8 weeks of treatment
8 weeks of treatment

Collaborators and Investigators

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

Sponsor

Gachon University Gil Medical Center

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

November 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 28, 2009

First Submitted That Met QC Criteria

October 28, 2009

First Posted (Estimate)

October 29, 2009

Study Record Updates

Last Update Posted (Estimate)

May 10, 2011

Last Update Submitted That Met QC Criteria

May 9, 2011

Last Verified

October 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GMC-200911

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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