We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Differential Metabolic Effects of Fenofibrate and Fatty Acid

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01003847
First Posted: October 29, 2009
Last Update Posted: May 10, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Gachon University Gil Medical Center
  Purpose
The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients

Condition Intervention Phase
Hypertriglyceridemia Drug: fenofibrate, fatty acid, placebo Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Gachon University Gil Medical Center:

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ]

Enrollment: 150
Study Start Date: November 2009
Study Completion Date: September 2010
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Active Comparator: Placebo Drug: fenofibrate, fatty acid, placebo
fenofibrate 160 mg, fatty acids 2 gm, placeob 8 weeks of treatment

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   25 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

  • Overt liver disease Chronic renal failure Hypothyroidism Myopathy Uncontrolled diabetes Severe hypertension
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01003847


Locations
Korea, Republic of
Gil Medical Center
Incheon, Korea, Republic of, 405-760
Sponsors and Collaborators
Gachon University Gil Medical Center
  More Information

Responsible Party: Dr. Koh, Gachon University
ClinicalTrials.gov Identifier: NCT01003847     History of Changes
Other Study ID Numbers: GMC-200911
First Submitted: October 28, 2009
First Posted: October 29, 2009
Last Update Posted: May 10, 2011
Last Verified: October 2010

Keywords provided by Gachon University Gil Medical Center:
Insulin resistance

Additional relevant MeSH terms:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Fenofibrate
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents