Trial Outcomes & Findings for Lovaza® and Microvascular Function in Type 2 Diabetes (NCT NCT00931879)

Last Updated: 2017-05-09

Results Overview

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 Nerve Above Fibular Amplitude, Sensory Median Nerve Wrist Amplitude, Sensory Ulnar, Sensory Sural Ankle Ampltiude Wrist Ampltiude

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

44 participants

Primary outcome timeframe

One year

Results posted on

2017-05-09

Participant Flow

Participant milestones

Participant milestones
Measure	Placebo 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. Placebo: 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.	Lovaza 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. 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.
Overall Study STARTED	22	22
Overall Study COMPLETED	19	19
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Lovaza® and Microvascular Function in Type 2 Diabetes

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Placebo n=19 Participants 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. Placebo: 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.	Lovaza n=19 Participants 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. 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.	Total n=38 Participants Total of all reporting groups
Age, Continuous	60.58 years STANDARD_DEVIATION 2.06 • n=5 Participants	58.21 years STANDARD_DEVIATION 1.70 • n=7 Participants	59.39 years STANDARD_DEVIATION 1.33 • n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants	12 Participants n=7 Participants	23 Participants n=5 Participants
Sex: Female, Male Male	8 Participants n=5 Participants	7 Participants n=7 Participants	15 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	17 Participants n=5 Participants	17 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Weight (lbs)	217.03 lbs STANDARD_DEVIATION 9.62 • n=5 Participants	215.16 lbs STANDARD_DEVIATION 10.38 • n=7 Participants	215.71 lbs STANDARD_DEVIATION 7.25 • n=5 Participants
BMI kg/m^2	34.04 kg/m^2 STANDARD_DEVIATION 1.17 • n=5 Participants	34.37 kg/m^2 STANDARD_DEVIATION 1.83 • n=7 Participants	34.10 kg/m^2 STANDARD_DEVIATION 1.11 • n=5 Participants
Qualifying triglyceride level (mg/dL)	215.05 mg/dL STANDARD_DEVIATION 12.51 • n=5 Participants	261.17 mg/dL STANDARD_DEVIATION 50.73 • n=7 Participants	237.48 mg/dL STANDARD_DEVIATION 24.42 • n=5 Participants
Total cholesterol (mg/dL)	152.26 (mg/dL) STANDARD_DEVIATION 6.56 • n=5 Participants	189.42 (mg/dL) STANDARD_DEVIATION 9.63 • n=7 Participants	170.84 (mg/dL) STANDARD_DEVIATION 6.51 • n=5 Participants
HDL cholesterol (mg/dL)	39.84 (mg/dL) STANDARD_DEVIATION 2.27 • n=5 Participants	43.32 (mg/dL) STANDARD_DEVIATION 2.81 • n=7 Participants	41.58 (mg/dL) STANDARD_DEVIATION 1.80 • n=5 Participants
LDL cholesterol (mg/dL)	75.84 (mg/dL) STANDARD_DEVIATION 5.80 • n=5 Participants	101.44 (mg/dL) STANDARD_DEVIATION 7.21 • n=7 Participants	88.30 (mg/dL) STANDARD_DEVIATION 5.01 • n=5 Participants
HbA1c (%)	7.82 % STANDARD_DEVIATION 0.35 • n=5 Participants	7.66 % STANDARD_DEVIATION 0.23 • n=7 Participants	7.73 % STANDARD_DEVIATION 0.21 • n=5 Participants
Fasting glucose (mg/dL)	155.89 (mg/dL) STANDARD_DEVIATION 9.18 • n=5 Participants	157.21 (mg/dL) STANDARD_DEVIATION 12.09 • n=7 Participants	156.55 (mg/dL) STANDARD_DEVIATION 7.49 • n=5 Participants
serum glutamate oxaloacetate transaminase(AST) (u/L)	22.16 (u/L) STANDARD_DEVIATION 1.50 • n=5 Participants	24.11 (u/L) STANDARD_DEVIATION 2.28 • n=7 Participants	24.00 (u/L) STANDARD_DEVIATION 8.44 • n=5 Participants
serum glutamate pyruvate transaminase (ALT) (u/L)	28.79 (u/L) STANDARD_DEVIATION 2.63 • n=5 Participants	31.05 (u/L) STANDARD_DEVIATION 3.84 • n=7 Participants	30.71 (u/L) STANDARD_DEVIATION 2.20 • n=5 Participants
Alkaline phosphatase (u/L)	77.89 (u/L) STANDARD_DEVIATION 6.55 • n=5 Participants	70.11 (u/L) STANDARD_DEVIATION 4.40 • n=7 Participants	74.63 (u/L) STANDARD_DEVIATION 4.62 • n=5 Participants
C-peptide (ng/mL)	4.66 (ng/mL) STANDARD_DEVIATION 0.40 • n=5 Participants	4.56 (ng/mL) STANDARD_DEVIATION 0.45 • n=7 Participants	4.61 (ng/mL) STANDARD_DEVIATION 0.30 • n=5 Participants
Insulin (uIU/mL)	39.54 (uIU/mL) STANDARD_DEVIATION 12.63 • n=5 Participants	26.23 (uIU/mL) STANDARD_DEVIATION 5.88 • n=7 Participants	32.88 (uIU/mL) STANDARD_DEVIATION 6.96 • n=5 Participants

PRIMARY outcome

Timeframe: One year

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Tibial Nerve Ankle Amplitude	7.28 uV Standard Error 0.94	7.14 uV Standard Error 1.13
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Tibial Nerve Popliteal Amplitude	4.08 uV Standard Error 0.58	3.80 uV Standard Error 0.73
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Peroneal Motor Nerve Below Fibular Amplitude	2.70 uV Standard Error 0.46	2.17 uV Standard Error 0.32
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Median Nerve Wrist Amplitude	6.89 uV Standard Error 0.60	7.24 uV Standard Error 0.55
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Median Nerve Elbow Amplitude	5.21 uV Standard Error 0.56	6.06 uV Standard Error 0.58
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Peroneal Motor Nerve Ankle Amplitude	2.97 uV Standard Error 0.47	2.55 uV Standard Error 0.36
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Peroneal Motor Nerve Above Fibular Amplitude	2.79 uV Standard Error 0.46	2.11 uV Standard Error 0.31
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Sensory Median Nerve Wrist Amplitude	22.96 uV Standard Error 3.04	26.56 uV Standard Error 5.09
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Sensory Ulnar Wrist Ampltiude	26.93 uV Standard Error 3.39	21.65 uV Standard Error 5.13
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. Sensory Sural Ankle Ampltiude	8.01 uV Standard Error 1.55	8.33 uV Standard Error 1.83

PRIMARY outcome

Timeframe: 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 of the beat to beat (NN) intervals and the TSP was calculated as well as the standard deviation of all normal R-R intervals (sdNN).

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Resting sdNN (ms)	31.924 ms Standard Error 15.509	40.748 ms Standard Error 16.050
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Resting rmsSD (ms)	28.838 ms Standard Error 15.592	72.075 ms Standard Error 30.165
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Deep Breathing sdNN (ms)	3.840 ms Standard Error 10.703	11.637 ms Standard Error 11.426
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Deep Breathing rmsSD (ms)	20.823 ms Standard Error 2.462	38.136 ms Standard Error 10.539
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Valsalva sdNN (ms)	0.136 ms Standard Error 0.077	6.333 ms Standard Error 13.516
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Valsalva rmsSD (ms)	12.752 ms Standard Error 15.511	26.668 ms Standard Error 20.514
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Standing sdNN (ms)	5.3786 ms Standard Error 10.361	8.622 ms Standard Error 12.080
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures. Standing rmsSD (ms)	23.725 ms Standard Error 20.551	38.243 ms Standard Error 21.850

PRIMARY outcome

Timeframe: One year

Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds. Cold Sensation Threshold-Finger (°C)	0.311 °C Standard Error 0.469	0.221 °C Standard Error 0.749
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds. Cold Pain Threshold-Finger (°C)	-1.167 °C Standard Error 1.525	-1.789 °C Standard Error 1.882
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds. Cold Sesnation Threshold-Toe (°C)	-1.169 °C Standard Error 1.183	-3.763 °C Standard Error 1.647
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds. Cold Pain Threshold-Toe (°C)	5.658 °C Standard Error 1.906	-1.405 °C Standard Error 2.158
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds. Cold Sensation Threshold-Dorsum (°C)	-2.062 °C Standard Error 1.484	-3.768 °C Standard Error 1.709
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds. Cold Pain Threshold-Dorsum (°C)	0.937 °C Standard Error 2.215	-1.739 °C Standard Error 2.339

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds Vibration Detection Threshold-Finger (% Change)	-0.375 % Change Standard Error 0.241	-1.102 % Change Standard Error 0.309
Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds Vibration Detection Threshold-Toe (% Change)	-3.750 % Change Standard Error 5.321	-8.169 % Change Standard Error 3.263

PRIMARY outcome

Timeframe: One year

Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress. IL1β (pg/ml)	1.13 pg/ml Standard Error 0.21	1.14 pg/ml Standard Error 0.31
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress. IKKβ (pg/ml)	0.98 pg/ml Standard Error 0.16	0.96 pg/ml Standard Error 0.17
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress. TLR4 (pg/ml)	1.11 pg/ml Standard Error 0.18	1.17 pg/ml Standard Error 0.29
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress. TNFα (pg/ml)	1.18 pg/ml Standard Error 0.19	0.76 pg/ml Standard Error 0.11
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress. JNK1 (pg/ml)	0.94 pg/ml Standard Error 0.15	0.75 pg/ml Standard Error 0.21
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress. toll-like receptor 2 (pg/ml)	0.90 pg/ml Standard Error 0.12	0.87 pg/ml Standard Error 0.16

PRIMARY outcome

Timeframe: One Year

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Tibial Nerve Popliteal Conduction Velocity	41.08 m/s Standard Error 6.58	37.53 m/s Standard Error 1.51
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Median Nerve Elbow Conduction Velocity	45.89 m/s Standard Error 1.76	46.74 m/s Standard Error 1.23
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Peroneal Motor Nerve Bel. Fib. Conduction Velocity	40.36 m/s Standard Error 1.35	39.96 m/s Standard Error 1.31
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Peroneal Motor Nerve Abo. Fib. Conduction Velocity	44.44 m/s Standard Error 3.65	45.00 m/s Standard Error 2.89
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Sensory Median Nerve Wrist Conduction Velocity	43.76 m/s Standard Error 3.08	46.59 m/s Standard Error 1.87
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Sensory Ulnar Wrist Conduction Velocity	46.94 m/s Standard Error 1.73	45.22 m/s Standard Error 1.75
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity. Sensory Sural Ankle Conduction Velocity	39.03 m/s Standard Error 1.61	38.60 m/s Standard Error 1.57

PRIMARY outcome

Timeframe: One Year

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Tibial Nerve Ankle Latency	5.08 ms Standard Error 0.28	5.29 ms Standard Error 0.31
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Tibial Nerve Popliteal Latency	14.65 ms Standard Error 0.51	16.41 ms Standard Error 0.66
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Median Nerve Wrist Latency	4.81 ms Standard Error 1.15	4.56 ms Standard Error 0.19
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Median Nerve Elbow Latency	9.16 ms Standard Error 0.43	8.79 ms Standard Error 0.35
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Peroneal Motor Nerve Ankle Latency	5.77 ms Standard Error 0.49	5.24 ms Standard Error 0.21
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Peroneal Motor Nerve Below Fibular Latency	13.58 ms Standard Error 0.77	13.20 ms Standard Error 0.40
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Peroneal Motor Nerve Above Fibular Latency	15.37 ms Standard Error 0.95	14.92 ms Standard Error 0.45
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Sensory Median Nerve Wrist Latency	3.48 ms Standard Error 0.33	3.01 ms Standard Error 0.16
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Sensory Ulnar Wrist Latency	2.51 ms Standard Error 0.13	2.62 ms Standard Error 0.11
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency. Sensory Sural Ankle Latency	3.68 ms Standard Error 0.15	3.70 ms Standard Error 0.14

PRIMARY outcome

Timeframe: One Year

Outcome measures

Outcome measures
Measure	Placebo n=19 Participants 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. Placebo: 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.	Omega-3-ethyl Esters 4g n=19 Participants 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. omega-3-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.
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction Tibial Nerve F-Wave Conduction	51.14 m/s Standard Error 3.02	55.89 m/s Standard Error 2.45
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction Median Nerve F-Wave Conduction	29.46 m/s Standard Error 1.09	29.44 m/s Standard Error 0.90
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction Peroneal Motor Nerve F-Wave Conduction	41.96 m/s Standard Error 3.09	47.47 m/s Standard Error 2.49

PRIMARY outcome

Timeframe: One Year

Population: Measures of vascular response to ischemic block and local warming at the dorsum of the foot were not reliably collected for this assessment due to the difficulty of analysis and the inability to properly distinguish a vascular response in patients.

Outcome measures

Outcome data not reported

Adverse Events

Placebo

Serious events: 4 serious events

Other events: 7 other events

Deaths: 0 deaths

Lovaza

Serious events: 2 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Placebo n=19 participants at risk 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. Placebo: 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.	Lovaza n=19 participants at risk 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. 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.
Respiratory, thoracic and mediastinal disorders Atypical Chest Pain	0.00% 0/19 • All adverse event data was collected per individual from time of consent to 6 months after consent.	5.3% 1/19 • Number of events 1 • All adverse event data was collected per individual from time of consent to 6 months after consent.
Injury, poisoning and procedural complications Head trauma due to accidental fall	5.3% 1/19 • Number of events 1 • All adverse event data was collected per individual from time of consent to 6 months after consent.	0.00% 0/19 • All adverse event data was collected per individual from time of consent to 6 months after consent.
Cardiac disorders Hospitilization due to low blood pressure and fainting	5.3% 1/19 • Number of events 1 • All adverse event data was collected per individual from time of consent to 6 months after consent.	0.00% 0/19 • All adverse event data was collected per individual from time of consent to 6 months after consent.
Cardiac disorders Overnight stay in ER for observation after experiencing chest pain	5.3% 1/19 • Number of events 1 • All adverse event data was collected per individual from time of consent to 6 months after consent.	0.00% 0/19 • All adverse event data was collected per individual from time of consent to 6 months after consent.
Surgical and medical procedures Planned surgery to treat Achalasia/Esophageal motility disorder	5.3% 1/19 • Number of events 1 • All adverse event data was collected per individual from time of consent to 6 months after consent.	0.00% 0/19 • All adverse event data was collected per individual from time of consent to 6 months after consent.
Surgical and medical procedures Emergency Surgery to relieve bile duct obstruction	0.00% 0/19 • All adverse event data was collected per individual from time of consent to 6 months after consent.	5.3% 1/19 • Number of events 1 • All adverse event data was collected per individual from time of consent to 6 months after consent.

Other adverse events

Additional Information

Dr. Henri Parson

Eastern Virginia Medical School

Phone: (757)446-7976

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place