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The Role of Lovaza? on Microvascular Function and Lipoprotein Profile in Type 2 Diabetes
This study is currently Recruiting
July 2011 By Eastern Virginia Medical School
First Recieved on June 17, 2009
Last Updated on July 8, 2011
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 triglyceride levels. Omega-3 fatty acids appear to exert beneficial effects on
vascular function that are independent of the changes in serum triglycerides. The efficacy
will be compared with a placebo given at the same duration. Efficacy of the drug will be
evaluated after 3 and 6 months of treatment. This timeline should be adequate for
evaluation of the primary neurophysiological endpoints. Previously, the investigators have
demonstrated that it is feasible to pharmacologically alter nerve fiber density in as little
as 18 weeks and that this correlates with subjective and objective measures of neurovascular
function. The investigators are predicting an enhancement of post-ischemic hyperemia of the
foot dorsum, where the dilative mechanism is primarily endothelium-dependent and a similar
improvement in heat-induced hyperemia.
||Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Resources/Links provided by NLM:
|Study Start Date:
|Estimated Primary Completion Date:
Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking placebo for 6 months.
Subjects are males or non-pregnant, non-lactating females age 18-80 years. All subjects must have been diagnosed with type 2 diabetes mellitus a minimum of two years according to the current ADA criteria and triglyceride levels above 149 mg/dL. Subjects in this arm will be taking 4 g of Lovaza per day for 6 months.
|Drug:omega-3-acie ethyl esters|
Lovaza (TM) (omega-3-ethyl esters) 1 gram Capsules are indicated as an adjunct to diet to reduce very high (>500 mg/dL) triglyceride (TG) levels in adult patients.
|Ages Eligible for Study:||18 Years|
|Genders Eligible for Study:||Both|
|Accepts Healthy Volunteers:||No|
1. Subjects may be males or non-pregnant, non-lactating females age 18-80 years.
2. Subjects must have been diagnosed with type 2 diabetes mellitus according to the
current ADA criteria.
3. Triglyceride levels above 149 mg/dL
4. Minimum of 2 years after diagnosis of type 2 diabetes
5. Prior to participation in this study, each subject must sign an informed consent
1. 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).
2. Presence of diabetic retinopathy that is more severe than "background" level.
3. Presence of diabetic nephropathy, defined by urine dipstick results greater than 300
mg/100 mL for protein (proteinuria).
4. Presence of clinically significant neuropathy that is clearly of non-diabetic origin,
e.g. alcoholic or autoimmune.
5. Bilateral amputation of lower extremities or foot ulcers involving the great toes.
Presence of neuroarthropathy (Charcot deformity) is allowable.
6. History of major macrovascular events such as myocardial infarction or stroke.
7. Participation in another clinical trial concurrently or within 30 days prior to entry
into this study.
8. 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.
9. Patients with moderate or severe hepatic insufficiency or abnormalities of liver
function defined as any liver enzymes (AST, ALT, alkaline phosphatase) greater than 3
times the upper limit of normal.
10. Presence of pedal edema.
11. Presence or history of heart failure NYHA Class II or greater.
12. Other serious medical conditions that in the opinion of the investigator, would
compromise the subject's participation in the study.
13. Concomitant use of medications known to exacerbate triglyceride levels, such as
- Investigator: Aaron I Vinik, MD, PhD - Principal Investigator - Eastern Virginia Medical School
- Investigator: Henri K Parson, PhD - Study Director - Eastern Virgina Medical School