Status:
COMPLETED
Lovaza® and Microvascular Function in Type 2 Diabetes
Lead Sponsor:
Eastern Virginia Medical School
Collaborating Sponsors:
GlaxoSmithKline
Conditions:
Hypertriglyceridemia
Diabetic Neuropathy
Eligibility:
All Genders
18-80 years
Phase:
PHASE4
Brief Summary
The objective of this study is to determine the efficacy of 6 months of 4 g/day oral Lovaza® on endothelial-dependent and heat-induced vasodilation in type 2 diabetics with neuropathy and elevated tri...
Detailed Description
This pilot study is a within-subject repeated measures design. This study will compare the neurophysiological and vascular responses to placebo and treatment with Lovaza® (omega-3-acid ethyl esters, R...
Eligibility Criteria
Inclusion
- Subjects may be males or non-pregnant, non-lactating females age 18-80 years.
- Subjects must have been diagnosed with type 2 diabetes mellitus according to the current ADA criteria.
- Triglyceride levels above 149 mg/dL
- Minimum of 2 years after diagnosis of type 2 diabetes
- Prior to participation in this study, each subject must sign an informed consent document.
Exclusion
- Presence of type 1 diabetes mellitus (defined as C-peptide \< 1 ng/ml or diabetes onset at \< 35 years of age in a non-obese patient).
- Presence of diabetic retinopathy that is more severe than "background" level.
- Presence of diabetic nephropathy, defined by urine dipstick results greater than 300 mg/100 mL for protein (proteinuria).
- Presence of clinically significant neuropathy that is clearly of non-diabetic origin, e.g. alcoholic or autoimmune.
- Bilateral amputation of lower extremities or foot ulcers involving the great toes. Presence of neuroarthropathy (Charcot deformity) is allowable.
- History of major macrovascular events such as myocardial infarction or stroke.
- Participation in another clinical trial concurrently or within 30 days prior to entry into this study.
- The use of ACE-inhibiting agents or angiotensin receptor blockade therapy (ARB) is allowed but must have been stable for at least 30 days prior to study entry and may not change during the course of the study. This is prudent due to their potential effects on blood flow.
- Patients with moderate or severe hepatic insufficiency or abnormalities of liver function defined as any liver enzymes (aspartate aminotransferase,alanine transaminase, alkaline phosphatase) greater than 3 times the upper limit of normal.
- Presence of pedal edema.
- Presence or history of heart failure New York Heart Association Class II or greater.
- Other serious medical conditions that in the opinion of the investigator, would compromise the subject's participation in the study.
- Concomitant use of medications known to exacerbate triglyceride levels, such as estrogens.
Key Trial Info
Start Date :
October 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT00931879
Start Date
October 1 2009
End Date
July 1 2012
Last Update
May 9 2017
Active Locations (1)
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1
Strelitz Diabetes Center
Norfolk, Virginia, United States, 23510