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

This study has been completed.
Sponsor:
Collaborators:
Heart and Diabetes Center North-Rhine Westfalia
Solvay Pharmaceuticals
Information provided by:
Ruhr University of Bochum
ClinicalTrials.gov Identifier:
NCT00328536
First received: May 19, 2006
Last updated: May 7, 2009
Last verified: May 2009
  Purpose

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.


Condition Intervention Phase
Atherosclerosis
Type 2 Diabetes Mellitus
Drug: Omacor
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effects of Treatment With Omacor for 6 Weeks on Preprandial and Postprandial Endothelial Function Following a High Fat Meal in Patients With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Ruhr University of Bochum:

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

Secondary Outcome Measures:
  • Baseline flow-mediated vasodilation after a 6-week treatment with Omacor

Estimated Enrollment: 34
Study Start Date: April 2007
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
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 and is present in states showing a high cardiovascular (CV) risk, such as active and passive smoking, dyslipidemia, arterial hypertension, obesity, hyperhomocysteinemia, coronary artery disease, congestive heart failure and type 1 and type 2 diabetes mellitus. Endothelial function is a variable with a large day-to-day variation and shows great excursions even within one day. Several factors might play a role such as hormonal status, physical activity, sleep quality, but the most important seems to be the postprandial state. Postprandial ED was demonstrated not only in patients with CV disease or diabetes, but even in healthy subjects. A large body of evidence has accumulated showing distinctive and cumulative effects of hyperglycemia and hypertriglyceridemia on postprandial ED. Since postprandial dysmetabolism was linked to CVD, ED was proposed to be the mechanism connecting them. Considering that the postprandial state covers most of our daytime, interventions targeting a reduction in postprandial ED might play a decisive role in atherosclerosis prevention.

For the treatment of postprandial ED several therapeutical approaches have been suggested such as folic acid, tetrahydrobiopterin, vitamins C and E and statins.

Some properties of omega-3 fatty acids suggest that such an impairment of postprandial endothelial dysfunction could be prevented by treatment with Omacor® and the purpose of our study is to demonstrate that a six-week therapy with Omacor prevents endothelial dysfunction in fasting state and following a high-fat meal.

Several controlled clinical studies conducted in persons with TM2DM or after myocardial infarction have shown that consumption of omega-3 long chain polyunsaturated fatty acids (n-3 PUFA) have several beneficial effects such as: lowers risk of primary cardiac arrest, reduces triglyceride levels, increases high-density lipoprotein levels, reduces platelet aggregability, acts anti-inflammatory and immune-modulating, lowers blood pressure and improves endothelial function.

Consumption of n-3 fatty acids was shown to positively influence platelet, fibrinolytic and vascular function in hypertensive type 2 diabetic patients. Mediterranean- style diet restores markers of endothelial dysfunction and inflammation in persons with metabolic syndrome and improves endothelial function in hypercholesterolemic men.

Since Omacor contains in high-dose purified n-3 fatty acids eicosapentaenoic and docosahexaenoic acid (EPA and DHA), our first hypothesis is that a 6-week therapy with 4g/d Omacor improves fasting endothelial function in persons with T2DM.

In patients with T2DM, a three-week diet with a high amount of polyunsaturated fatty acids compared to a diet with a high amount of monounsaturated fatty acids, produces a significantly lower increase in postprandial lipemia after an oral fat load. Since postprandial lipemia induces transient endothelial dysfunction, our second hypothesis is that treatment with Omacor prevents postprandial impairment of endothelial function after a high fat meal.

  Eligibility

Ages Eligible for Study:   35 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus

Exclusion Criteria:

  • History of myocardial infarction, stroke
  • Severe diabetes complications
  • Severe hypo- or hypertension
  • Chronic alcohol abuse
  • Renal failure
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00328536

Locations
Germany
Heart- and Diabetes Centre NRW, Diabetes Clinic
Bad Oeynhausen, NRW, Germany, 32545
Sponsors and Collaborators
Ruhr University of Bochum
Heart and Diabetes Center North-Rhine Westfalia
Solvay Pharmaceuticals
Investigators
Principal Investigator: Diethelm Tschoepe, MD, Prof. Heart and Diabetes Center North-Rhine Westfalia
Principal Investigator: Alin Stirban, MD Heart and Diabetes Center North-Rhine Westfalia
  More Information

No publications provided

Responsible Party: Heart and Diabetes Center, Diabetes Center
ClinicalTrials.gov Identifier: NCT00328536     History of Changes
Other Study ID Numbers: OMACOR-D-01/06
Study First Received: May 19, 2006
Last Updated: May 7, 2009
Health Authority: Germany: Ethics Commission

Keywords provided by Ruhr University of Bochum:
flow-mediated vasodilatation
endothelial dysfunction
omega-3 fatty acids
type 2 diabetes mellitus
postprandial state

Additional relevant MeSH terms:
Arteriosclerosis
Atherosclerosis
Diabetes Mellitus
Diabetes Mellitus, Type 2
Arterial Occlusive Diseases
Cardiovascular Diseases
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 22, 2014