NCT00931879

The Role of Lovaza® on Microvascular Function and Lipoprotein Profile in Type 2 Diabetes

Completed Phase 4 Results posted Last updated 28 March 2017

What this trial tests

Phase 4 trial testing omega-3-ethyl esters in Hypertriglyceridemia in 44 participants. Completed in 1 July 2012.

Timeline

1 October 2009

Primary endpoint
1 July 2012

1 July 2012

Quick facts

Lead sponsor	Eastern Virginia Medical School
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	44
Start date	1 October 2009
Primary completion	1 July 2012
Estimated completion	1 July 2012
Sites	1 location across United States

Drugs / interventions tested

• omega-3-ethyl esters
• Placebo

Conditions studied

• Hypertriglyceridemia — all drugs for Hypertriglyceridemia →
• Diabetic Neuropathy — all drugs for Diabetic Neuropathy →

Sponsor

Eastern Virginia Medical School

Who can join

Adults 18 to 80, any sex, with Hypertriglyceridemia or Diabetic Neuropathy. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.
  Time frame: One year
  19 participants in each arm( placebo or omega-3-ethyl esters 4g) were analyzed . Conduction velocities and amplitude of the following nerves were compared between each arm: Tibial Nerve Ankle Amplitude, Tibial Nerve Popliteal Amplitude, Median Nerve Wrist Amplitude, Median Nerve Elbow Amplitude, Peroneal Motor Nerve Ankle Amplitude, Peroneal Motor Nerve Below Fibular Amplitude, Peroneal Motor Nerv
• Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.
  Time frame: One year
  Quantitative Autonomic Function Tests (QAFTs) were performed. Primarily, power spectral analysis of heart rate variability (HRV) and time- and frequency-domain analyses, including measures of the sympathetic and parasympathetic control of the heart beat (R-R interval), were recorded with deep breathing, Valsalva, and standing from the sitting position maneuvers. Additionally, the sample difference
• Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.
  Time frame: One year
  Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.
• Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds
  Time frame: One year
  Quantitative Sensory Tests (QSTs), including vibration detection threshold, were used to evaluate peripheral sensory perception. Mean represents percent change of total group. Measurements taken at baseline and at one year.
• Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.
  Time frame: One year
  Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.
• Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.
  Time frame: One Year

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.