Status:

COMPLETED

Omacor for the Treatment of Vascular Dysfunction in Patients With Type 2 Diabetes Mellitus

Lead Sponsor:

Ruhr University of Bochum

Collaborating Sponsors:

Heart and Diabetes Center North-Rhine Westfalia

Solvay Pharmaceuticals

Conditions:

Atherosclerosis

Type 2 Diabetes Mellitus

Eligibility:

All Genders

35-70 years

Phase:

PHASE4

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 diab...

Detailed Description

Patients with type 2 diabetes mellitus (T2DM) have a 2 to 5-fold increase in cardiovascular mortality compared to non-diabetics. Endothelial dysfunction (ED) is an early messenger of atherosclerosis ...

Eligibility Criteria

Inclusion

  • Type 2 diabetes mellitus

Exclusion

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

Key Trial Info

Start Date :

April 1 2007

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

November 1 2008

Estimated Enrollment :

34 Patients enrolled

Trial Details

Trial ID

NCT00328536

Start Date

April 1 2007

End Date

November 1 2008

Last Update

May 8 2009

Active Locations (1)

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1

Heart- and Diabetes Centre NRW, Diabetes Clinic

Bad Oeynhausen, North Rhine-Westphalia, Germany, 32545