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Vascular and Metabolic Effects of Omega-3 Fatty Acids

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ClinicalTrials.gov Identifier: NCT01660932
Recruitment Status : Completed
First Posted : August 9, 2012
Last Update Posted : November 4, 2014
Sponsor:
Information provided by (Responsible Party):
Kwang Kon Koh, Gachon University Gil Medical Center

Brief Summary:
The investigators hypothesize that omega does-dependently improves vascular and insulin resistance.

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

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Study Start Date : March 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Triglycerides

Arm Intervention/treatment
Placebo Comparator: placebo
placebo
Drug: placebo
Active Comparator: omega 1
omega 1 gm
Drug: omega
Active Comparator: omega 2
omega 2 gm
Drug: omega
Active Comparator: omega 4
omega 4 gm
Drug: omega



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 80 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 (HbA1c > 9%), severe hypertension, stroke, acute coronary events, coronary revascularization within the preceding 3 months, or alcohol abuse

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): NCT01660932


Locations
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
ClinicalTrials.gov Identifier: NCT01660932     History of Changes
Other Study ID Numbers: GMC-201103
First Posted: August 9, 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:
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases