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
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Tracking Information | |||||||
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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 |
Postprandial (2, 4 and 6 hours) flow-mediated vasodilation after a 6-week treatment with Omacor | ||||||
Original Primary Outcome Measures ICMJE |
Postprandial (2,4 and 6 hours) flow-mediated vasodilataion after a 6-week treatment with Oamcor | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
Baseline flow-mediated vasodilation after a 6-week treatment with Omacor | ||||||
Original Secondary Outcome Measures ICMJE |
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. |
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Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 4 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Double Primary Purpose: Treatment |
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Condition ICMJE |
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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. |
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Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 |
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Investigators ICMJE |
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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 |