Clinical trial NCT00959842: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Official title: Effects of Lovaza on Lipoprotein Composition and Function in Mild Hypertriglyceridemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hypertriglyceridemia
Keywords: hypertriglyceridemia
Omega-3 Fatty Acids
Lipoprotein
Statin
Lovaza
Lead sponsor: Sanford Research
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2009-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Detailed description: This study will build upon a previous finding that showed a triglyceride lowering effect of prescription omega-3 in combined therapy with statins. The proposed study will use a simple change from baseline design on 15 subjects who are hypertriglyceridemic on stable statin therapy. The protocol involves 3 study visits; each involve drawing a blood sample: day 1 - screening (blood draw for qualification and safety); day 7 - before taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline), day 63 -after taking prescription omega-3 fatty acids (Lovaza, 4 capsules/d; GlaxoSmithKline). The proposed study will include up to 15 subjects and will utilize several different measures of lipoprotein structure and function. The investigators will measure functional parameters such as the binding affinity of lipoproteins before and after treatment with omega-3 fatty acids. The investigators will also measure fatty acid, oxylipin and apolipoprotein content of plasma, very-low-density lipoprotein (VLDL), low-density lipoprotein (LDL) and high-density lipoprotein (HDL).

Eligibility criteria: Inclusion Criteria:

* 18-79 years
* Stable does of statins ≥ 8 weeks prior to screening
* Good health by medical history, physical exam, electrocardiogram, laboratory test (e.g., serum chem., urinalysis)
* Mean fasting serum triglyceride of two most recent tests in medical record ≥ 200 and \< 500 mg/dL
* Mean LDL-cholesterol of two most recent tests in medical record ≤ 1.1 × NCEP ATP III goal

Exclusion Criteria:

* Medications, vitamin pills, nutritional supplements or herbal preparations deemed exclusionary per primary investigator for possible interference
* Poorly controlled diabetes mellitus (e.g. \[HbA1c\] \> 8.0%)
* History of a cardiovascular event
* Past revascularization procedure
* Past aortic aneurysm or an aortic dissection \< 6 months prior to screening
* History of pancreatitis
* Sensitivity to any statin OR to omega-3 fatty acids or fish products
* Poorly controlled hypertension (i.e.: \>=160 systolic (resting) and/or \>=100 diastolic (resting)) at 2 consecutive visits
* Serum Creatinine ≥ 2.0 mg/dL
* Serum transaminase \> 1.5 × upper limit of normal (ULN); including aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\]; 31 U/L for AST, 45 U/L for ALT
* Creatine Kinase (CK) \> 3.0 × ULN
* Taking other triglyceride lowering drugs (e.g., niacin, fibrates) or fish oil supplements providing more than 500 mg of EPA+DHA per day
* Contraindications for Lovaza per product insert
* Women who are pregnant or nursing

Primary outcomes:
measure: HDL 15-HEPE
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Sanford Research/USD
state: South Dakota
Study officials:
affiliation: Sanford Research/USD
name: Gregory C Shearer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newman JW, Pedersen TL, Brandenburg VR, Harris WS, Shearer GC. Effect of omega-3 fatty acid ethyl esters on the oxylipin composition of lipoproteins in hypertriglyceridemic, statin-treated subjects. PLoS One. 2014 Nov 13;9(11):e111471. doi: 10.1371/journal.pone.0111471. eCollection 2014.