NCT01660932

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
176

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Mar 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2011

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2012

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

August 8, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

November 4, 2014

Status Verified

August 1, 2012

Enrollment Period

1.4 years

First QC Date

August 8, 2012

Last Update Submit

November 1, 2014

Conditions

Hypertriglyceridemia

Keywords

insulin resistance

Outcome Measures

Primary Outcomes (1)

  • flow-mediated dilation

    8 weeks of treatment

Secondary Outcomes (1)

  • insulin resistance

    8 weeks of treatment

Study Arms (4)

placebo

PLACEBO COMPARATOR

placebo

Drug: placebo

omega 1

ACTIVE COMPARATOR

omega 1 gm

Drug: omega

omega 2

ACTIVE COMPARATOR

omega 2 gm

Drug: omega

omega 4

ACTIVE COMPARATOR

omega 4 gm

Drug: omega

Interventions

placeboDRUG
placebo
omegaDRUG
omega 1omega 2omega 4

Eligibility Criteria

Age25 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hypertriglyceridemia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gil Medical Center

Incheon, 405-760, South Korea

Location

MeSH Terms

Conditions

HypertriglyceridemiaInsulin Resistance

Condition Hierarchy (Ancestors)

HyperlipidemiasDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesHyperinsulinismGlucose Metabolism Disorders

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 8, 2012

First Posted

August 9, 2012

Study Start

March 1, 2011

Primary Completion

August 1, 2012

Study Completion

September 1, 2012

Last Updated

November 4, 2014

Record last verified: 2012-08

Locations

KR(1)