Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

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. Identifier: NCT01666041
Recruitment Status : Completed
First Posted : August 16, 2012
Last Update Posted : November 4, 2014
Information provided by (Responsible Party):
Kwang Kon Koh, Gachon University Gil Medical Center

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

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: placebo Drug: fenofibrate/omega Drug: fenofibrate Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : January 2012
Actual Primary Completion Date : February 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Fenofibrate
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: placebo
Drug: placebo
Active Comparator: fenofibrate/omega
Drug: fenofibrate/omega
Active Comparator: fenofibrate
Drug: fenofibrate

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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • hypertriglyceridemia

Exclusion Criteria:

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

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 identifier (NCT number): NCT01666041

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

Responsible Party: Kwang Kon Koh, professor, Gachon University Gil Medical Center Identifier: NCT01666041     History of Changes
Other Study ID Numbers: GMC-201202
First Posted: August 16, 2012    Key Record Dates
Last Update Posted: November 4, 2014
Last Verified: August 2012

Keywords provided by Kwang Kon Koh, Gachon University Gil Medical Center:
insulin resistance

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents