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Differential Metabolic Effects of Fenofibrate and Fatty Acid

This study has been completed.
Sponsor:
Information provided by:
Gachon University Gil Medical Center
ClinicalTrials.gov Identifier:
NCT01003847
First received: October 28, 2009
Last updated: May 9, 2011
Last verified: October 2010
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment

Resource links provided by NLM:

Drug Information available for: Fenofibrate
U.S. FDA Resources

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

Primary Outcome Measures:
  • flow-mediated dilation [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • insulin resistance [ Time Frame: 8 weeks of treatment ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   25 Years to 75 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01003847

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

No publications provided

Responsible Party: Dr. Koh, Gachon University
ClinicalTrials.gov Identifier: NCT01003847     History of Changes
Other Study ID Numbers: GMC-200911
Study First Received: October 28, 2009
Last Updated: May 9, 2011
Health Authority: South Korea: Institutional Review Board

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
Pharmacologic Actions
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 21, 2013