NCT00328536

Brief Summary

The purpose of the study is to determine whether a 6-week treatment with 4 g Omacor/day improves the baseline and postprandial endothelial function (after a high-fat meal) in patients with type 2 diabetes mellitus.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2007

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

First Submitted

Initial submission to the registry

May 19, 2006

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 22, 2006

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2008

Completed
Last Updated

May 8, 2009

Status Verified

May 1, 2009

Enrollment Period

1.6 years

First QC Date

May 19, 2006

Last Update Submit

May 7, 2009

Conditions

AtherosclerosisType 2 Diabetes Mellitus

Keywords

flow-mediated vasodilatationendothelial dysfunctionomega-3 fatty acidstype 2 diabetes mellituspostprandial state

Outcome Measures

Primary Outcomes (1)

  • Postprandial (2, 4 and 6 hours) flow-mediated vasodilation after a 6-week treatment with Omacor

Secondary Outcomes (1)

  • Baseline flow-mediated vasodilation after a 6-week treatment with Omacor

Interventions

OmacorDRUG

Eligibility Criteria

Age35 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 2 diabetes mellitus

You may not qualify if:

  • History of myocardial infarction, stroke
  • Severe diabetes complications
  • Severe hypo- or hypertension
  • Chronic alcohol abuse
  • Renal failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Heart- and Diabetes Centre NRW, Diabetes Clinic

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location

Related Publications (1)

  • Stirban A, Nandrean S, Gotting C, Stratmann B, Tschoepe D. Effects of n-3 polyunsaturated fatty acids (PUFAs) on circulating adiponectin and leptin in subjects with type 2 diabetes mellitus. Horm Metab Res. 2014 Jun;46(7):490-2. doi: 10.1055/s-0033-1363225. Epub 2013 Dec 19.

    PMID: 24356795DERIVED

MeSH Terms

Conditions

AtherosclerosisDiabetes Mellitus, Type 2

Interventions

Omacor

Condition Hierarchy (Ancestors)

ArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Diethelm Tschoepe, MD, Prof.

    Heart and Diabetes Center North-Rhine Westfalia

    PRINCIPAL INVESTIGATOR

  • Alin Stirban, MD

    Heart and Diabetes Center North-Rhine Westfalia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 19, 2006

First Posted

May 22, 2006

Study Start

April 1, 2007

Primary Completion

November 1, 2008

Study Completion

November 1, 2008

Last Updated

May 8, 2009

Record last verified: 2009-05

Locations

DE(1)