Vascular and Metabolic Effects of Fenofibrate/Omega vs Fenofibrate

This study has been completed.
Information provided by (Responsible Party):
Kwang Kon Koh, Gachon University Gil Medical Center Identifier:
First received: August 15, 2012
Last updated: November 1, 2014
Last verified: August 2012

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

Condition Intervention Phase
Drug: placebo
Drug: fenofibrate/omega
Drug: fenofibrate
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:

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 ]

Estimated Enrollment: 120
Study Start Date: January 2012
Study Completion Date: July 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: placebo
Drug: placebo
Active Comparator: fenofibrate/omega
Drug: fenofibrate/omega
Active Comparator: fenofibrate
Drug: fenofibrate


Ages Eligible for Study:   25 Years to 80 Years
Genders Eligible for Study:   Both
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
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Please refer to this study by its identifier: NCT01666041

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: Kwang Kon Koh, professor, Gachon University Gil Medical Center Identifier: NCT01666041     History of Changes
Other Study ID Numbers: GMC-201202
Study First Received: August 15, 2012
Last Updated: November 1, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Gachon University Gil Medical Center:
insulin resistance

Additional relevant MeSH terms:
Lipid Metabolism Disorders
Metabolic Diseases
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses processed this record on October 09, 2015