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Differential Metabolic Effects of Fenofibrate and Fatty Acid

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ClinicalTrials.gov Identifier: NCT01003847
Recruitment Status : Completed
First Posted : October 29, 2009
Last Update Posted : May 10, 2011
Sponsor:
Information provided by:
Gachon University Gil Medical Center

Brief Summary:
The investigators hypothesize that fenofibrate and fatty acid may have different metabolic effects in hypertriglyceridemic patients

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: fenofibrate, fatty acid, placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : November 2009
Actual Primary Completion Date : September 2010
Actual Study Completion Date : September 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides
Drug Information available for: Fenofibrate

Arm Intervention/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

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




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 ]


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Ages Eligible for Study:   25 Years to 75 Years   (Adult, Older Adult)
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

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

Responsible Party: Dr. Koh, Gachon University
ClinicalTrials.gov Identifier: NCT01003847     History of Changes
Other Study ID Numbers: GMC-200911
First Posted: October 29, 2009    Key Record Dates
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