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

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ClinicalTrials.gov Identifier: NCT00328536
Recruitment Status : Completed
First Posted : May 22, 2006
Last Update Posted : May 8, 2009
Sponsor:
Collaborators:
Heart and Diabetes Center North-Rhine Westfalia
Solvay Pharmaceuticals
Information provided by:
Ruhr University of Bochum

Tracking Information
First Submitted Date  ICMJE May 19, 2006
First Posted Date  ICMJE May 22, 2006
Last Update Posted Date May 8, 2009
Study Start Date  ICMJE April 2007
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
Postprandial (2, 4 and 6 hours) flow-mediated vasodilation after a 6-week treatment with Omacor
Original Primary Outcome Measures  ICMJE
 (submitted: May 19, 2006)
Postprandial (2,4 and 6 hours) flow-mediated vasodilataion after a 6-week treatment with Oamcor
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 27, 2006)
Baseline flow-mediated vasodilation after a 6-week treatment with Omacor
Original Secondary Outcome Measures  ICMJE
 (submitted: May 19, 2006)
Baseline flow-mediated vasodilataion after a 6-week treatment with Oamcor
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Omacor for the Treatment of Vascular Dysfunction in Patients With Type 2 Diabetes Mellitus
Official Title  ICMJE 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
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double
Primary Purpose: Treatment
Condition  ICMJE
  • Atherosclerosis
  • Type 2 Diabetes Mellitus
Intervention  ICMJE Drug: Omacor
Study Arms  ICMJE Not Provided
Publications * Stirban A, Nandrean S, Götting 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: May 19, 2006)
34
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2008
Actual Primary Completion Date November 2008   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00328536
Other Study ID Numbers  ICMJE OMACOR-D-01/06
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Heart and Diabetes Center, Diabetes Center
Study Sponsor  ICMJE Ruhr University of Bochum
Collaborators  ICMJE
  • Heart and Diabetes Center North-Rhine Westfalia
  • Solvay Pharmaceuticals
Investigators  ICMJE
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
PRS Account Ruhr University of Bochum
Verification Date May 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP