HypertriglyceridemiaPhase 4NCT00931879

Lovaza® and Microvascular Function in Type 2 Diabetes

A Phase 4 study testing omega-3-ethyl esters in people with Hypertriglyceridemia and Diabetic Neuropathy, run by Eastern Virginia Medical School at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Hypertriglyceridemia, Diabetic Neuropathy
What is being tested?: omega-3-ethyl esters
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Oct 2009to Jul 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

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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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Strelitz Diabetes Center
Norfolk, Virginia, 23510

Other trials in United States

About this study

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

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.

Read the 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, Reliant Pharmaceuticals, Inc.) in subjects with type 2 diabetes, neuropathy, and dyslipidemia.

Lovaza's potential mechanism of action is the inhibition of acyl Coenzyme A:1, 2-diacylglycerol acyltransferase and increased peroxisomal β-oxidation in the liver.

Subjects will be recruited and a baseline of physiological, neurological and hematological profile established for each patient. Forty-four subjects (20 in the active arm, 20 in the placebo arm, and 2 replacements for each arm) will receive 4 g/day Lovaza® tablets or placebo for a period of 6 months. All subjects will receive a physical and neurological exam as well as neurovascular function testing. This includes nerve conduction studies, quantitative sensory testing, quantitative autonomic testing, and skin blood flow testing, which includes, ischemia reperfusion. Lab tests include an insulin resistance profile, hepatic and renal function profiles, lipid profile, C-reactive protein, thyroid stimulating hormone, and fatty acids. Other tests include inflammatory markers such as adiponectin and tumor necrosis factor-α. The study is powered to detect differences in microvascular function after 6 months of Lovaza® and differences in ethnic responses.

Conditions: Hypertriglyceridemia, Diabetic Neuropathy
Being tested: omega-3-ethyl esters, Placebo
Medical subject headings: Hypertriglyceridemia, Diabetic Neuropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

omega-3-ethyl estersDrug
Also called Lovaza
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.
PlaceboDrug
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.

Study groups in NCT00931879
Study group	Role	What they receive
Placebo	Placebo comparator	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. Receives: Drug: Placebo
omega-3-ethyl esters 4g	Active comparator	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. Receives: Drug: omega-3-ethyl esters

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.
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
Measured: One year
Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.
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).
Measured: One year
Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.
Quantitative Sensory Tests (QSTs), including, cold sensation threshold, cold pain threshold and vibration detection threshold, were used to evaluate peripheral sensory perception.
Measured: One year
Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds
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.
Measured: One year
Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.
Oxidative stress/inflammatory markers (IL1β, IKKβ, TLR4, TNF-α, JNK1, toll-like receptor 2) were assessed through a meal challenge.
Measured: One year
Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.
Measured: One Year
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.
Measured: One Year
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction
Measured: One Year
Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.
Measured: One Year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 2009Jul 2012

First posted2 Jul 2009 (estimated)
Study startOct 2009
Primary completionJul 2012
Study completionJul 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00931879
Sponsor's protocol ID: LVZ111903
Status last verified: Mar 2017
First submitted: 17 Jun 2009
Last updated: 9 May 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 9 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Role of Lovaza® on Microvascular Function and Lipoprotein Profile in Type 2 Diabetes
ClinicalTrials.gov ID: NCT00931879
Acronym / sponsor ID: LVZ111903
Conditions: Hypertriglyceridemia, Diabetic Neuropathy
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Eastern Virginia Medical SchoolUniversity, hospital or other
Collaborators: GlaxoSmithKline
Study start: Oct 2009
Primary completion: Jul 2012 (actual)
Study completion: Jul 2012 (actual)
First posted: 2 Jul 2009 (estimated)
Results: Posted 9 May 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Lovaza's potential mechanism of action is the inhibition of acyl Coenzyme A:1, 2-diacylglycerol acyltransferase and increased peroxisomal β-oxidation in the liver.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Placebo	Placebo comparator	Drug: PlaceboSubjects 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	Active comparator	Drug: omega-3-ethyl estersSubjects 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.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (13 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
omega-3-ethyl estersAlso: LovazaLovaza (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.	Drug	omega-3-ethyl esters 4g
PlaceboSubjects 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.	Drug	Placebo

Primary outcome

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 Nerve Above Fibular Amplitude, Sensory Median Nerve Wrist Amplitude, Sensory Ulnar, Sensory Sural Ankle Ampltiude Wrist Ampltiude
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 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).
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
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.
Time frame: One Year
Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction
Time frame: One Year
Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.
Time frame: One Year

Results and safety

Results posted to the registry on 9 May 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	22	19
Lovaza	22	19

Primary outcome: Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.

Time frame: One year. Mean (Standard Error). Unit: uV

Measure	Placebo n = 19	Omega-3-ethyl Esters 4g n = 19
Tibial Nerve Ankle Amplitude	7.28 (0.94)	7.14 (1.13)
Tibial Nerve Popliteal Amplitude	4.08 (0.58)	3.80 (0.73)
Median Nerve Wrist Amplitude	6.89 (0.60)	7.24 (0.55)
Median Nerve Elbow Amplitude	5.21 (0.56)	6.06 (0.58)
Peroneal Motor Nerve Ankle Amplitude	2.97 (0.47)	2.55 (0.36)
Peroneal Motor Nerve Below Fibular Amplitude	2.70 (0.46)	2.17 (0.32)
Peroneal Motor Nerve Above Fibular Amplitude	2.79 (0.46)	2.11 (0.31)
Sensory Median Nerve Wrist Amplitude	22.96 (3.04)	26.56 (5.09)

Primary outcome: Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.

Time frame: One year. Mean (Standard Error). Unit: ms

Measure	Placebo n = 19	Lovaza n = 19
Resting sdNN (ms)	31.924 (15.509)	40.748 (16.050)
Resting rmsSD (ms)	28.838 (15.592)	72.075 (30.165)
Deep Breathing sdNN (ms)	3.840 (10.703)	11.637 (11.426)
Deep Breathing rmsSD (ms)	20.823 (2.462)	38.136 (10.539)
Valsalva sdNN (ms)	0.136 (0.077)	6.333 (13.516)
Valsalva rmsSD (ms)	12.752 (15.511)	26.668 (20.514)
Standing sdNN (ms)	5.3786 (10.361)	8.622 (12.080)
Standing rmsSD (ms)	23.725 (20.551)	38.243 (21.850)

Primary outcome: Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.

Time frame: One year. Mean (Standard Error). Unit: °C

Measure	Placebo n = 19	Omega-3-ethyl Esters 4g n = 19
Cold Sensation Threshold-Finger (°C)	0.311 (0.469)	0.221 (0.749)
Cold Pain Threshold-Finger (°C)	-1.167 (1.525)	-1.789 (1.882)
Cold Sesnation Threshold-Toe (°C)	-1.169 (1.183)	-3.763 (1.647)
Cold Pain Threshold-Toe (°C)	5.658 (1.906)	-1.405 (2.158)
Cold Sensation Threshold-Dorsum (°C)	-2.062 (1.484)	-3.768 (1.709)
Cold Pain Threshold-Dorsum (°C)	0.937 (2.215)	-1.739 (2.339)

Primary outcome: Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds

Time frame: One year. Mean (Standard Error). Unit: % Change

Measure	Placebo n = 19	Omega-3-ethyl Esters 4g n = 19
Vibration Detection Threshold-Finger (% Change)	-0.375 (0.241)	-1.102 (0.309)
Vibration Detection Threshold-Toe (% Change)	-3.750 (5.321)	-8.169 (3.263)

Adverse events

Time frame: All adverse event data was collected per individual from time of consent to 6 months after consent.. Other adverse events reported at 3% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	4 of 19 (21.1%)	7 of 19 (36.8%)	Not reported
Lovaza	2 of 19 (10.5%)	8 of 19 (42.1%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aaron I Vinik, MD, PhD principal investigator

Eastern Virginia Medical School

Henri K Parson, PhD study director

Eastern Virgina Medical School

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing omega-3-ethyl esters in people with Hypertriglyceridemia and Diabetic Neuropathy, run by Eastern Virginia Medical School at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude. (time frame: One year). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00931879.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2017.