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Lovaza® and Microvascular Function in Type 2 Diabetes

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Aaron I. Vinik, MD, PhD, Eastern Virginia Medical School
ClinicalTrials.gov Identifier:
NCT00931879
First received: June 17, 2009
Last updated: March 28, 2017
Last verified: March 2017
Results First Received: February 4, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator;   Primary Purpose: Treatment
Conditions: Hypertriglyceridemia
Diabetic Neuropathy
Interventions: Drug: omega-3-ethyl esters
Drug: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.


Participant Flow:   Overall Study
    Placebo   Lovaza
STARTED   22   22 
COMPLETED   19   19 
NOT COMPLETED   3   3 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
The study was powered at 0.80 for a two-tail analysis with a sensitivity of a 30% delta in blood flow in 40 subjects. The standard deviation of the measurements was calculated at 45% of the treatment group mean. This assessment of variance could accommodate for 9% attrition or data loss in the study. 44 patients will be recruited in total.

Reporting Groups
  Description
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.

Total Total of all reporting groups

Baseline Measures
   Placebo   Lovaza   Total 
Overall Participants Analyzed 
[Units: Participants]
 19   19   38 
Age 
[Units: Years]
Mean (Standard Deviation)
 60.58  (2.06)   58.21  (1.70)   59.39  (1.33) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      11  57.9%      12  63.2%      23  60.5% 
Male      8  42.1%      7  36.8%      15  39.5% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      1   5.3%      2  10.5%      3   7.9% 
White      17  89.5%      17  89.5%      34  89.5% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      1   5.3%      0   0.0%      1   2.6% 
Weight (lbs) 
[Units: Lbs]
Mean (Standard Deviation)
 217.03  (9.62)   215.16  (10.38)   215.71  (7.25) 
BMI kg/m^2 
[Units: Kg/m^2]
Mean (Standard Deviation)
 34.04  (1.17)   34.37  (1.83)   34.10  (1.11) 
Qualifying triglyceride level (mg/dL) 
[Units: mg/dL]
Mean (Standard Deviation)
 215.05  (12.51)   261.17  (50.73)   237.48  (24.42) 
Total cholesterol (mg/dL) 
[Units: (mg/dL)]
Mean (Standard Deviation)
 152.26  (6.56)   189.42  (9.63)   170.84  (6.51) 
HDL cholesterol (mg/dL) 
[Units: (mg/dL)]
Mean (Standard Deviation)
 39.84  (2.27)   43.32  (2.81)   41.58  (1.80) 
LDL cholesterol (mg/dL) 
[Units: (mg/dL)]
Mean (Standard Deviation)
 75.84  (5.80)   101.44  (7.21)   88.30  (5.01) 
HbA1c (%) 
[Units: %]
Mean (Standard Deviation)
 7.82  (0.35)   7.66  (0.23)   7.73  (0.21) 
Fasting glucose (mg/dL) 
[Units: (mg/dL)]
Mean (Standard Deviation)
 155.89  (9.18)   157.21  (12.09)   156.55  (7.49) 
serum glutamate oxaloacetate transaminase(AST) (u/L) 
[Units: (u/L)]
Mean (Standard Deviation)
 22.16  (1.50)   24.11  (2.28)   24.00  (8.44) 
serum glutamate pyruvate transaminase (ALT) (u/L) 
[Units: (u/L)]
Mean (Standard Deviation)
 28.79  (2.63)   31.05  (3.84)   30.71  (2.20) 
Alkaline phosphatase (u/L) 
[Units: (u/L)]
Mean (Standard Deviation)
 77.89  (6.55)   70.11  (4.40)   74.63  (4.62) 
C-peptide (ng/mL) 
[Units: (ng/mL)]
Mean (Standard Deviation)
 4.66  (0.40)   4.56  (0.45)   4.61  (0.30) 
Insulin (uIU/mL) 
[Units: (uIU/mL)]
Mean (Standard Deviation)
 39.54  (12.63)   26.23  (5.88)   32.88  (6.96) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Conduction Amplitude.   [ Time Frame: One year ]

2.  Primary:   Measurements of Indices of Large and Small Fiber Nerve Function Including Heart Rate Variation Measures.   [ Time Frame: One year ]

3.  Primary:   Measurements of Indices of Large and Small Fiber Nerve Function Using Vibration and Thermal Thresholds.   [ Time Frame: One year ]

4.  Primary:   Percent Change in Measurements of Indices of Large and Small Fiber Nerve Function Including Vibration Thresholds   [ Time Frame: One year ]

5.  Primary:   Measurements of Indices of Large and Small Fiber Nerve Function Including Markers of Inflammation and Oxidative Stress.   [ Time Frame: One year ]

6.  Primary:   Efficacy Measures Are Nerve Conduction Studies; Specifically, Increases in Conduction Velocity.   [ Time Frame: One Year ]

7.  Primary:   Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in Latency.   [ Time Frame: One Year ]

8.  Primary:   Efficacy Measures Are Nerve Conduction Studies, Specifically Changes in F-wave Conduction   [ Time Frame: One Year ]

9.  Primary:   Efficacy Measures Examining Increased Vascular Response to Ischemic Block and to Local Warming at the Dorsum of the Foot.   [ Time Frame: One Year ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Henri Parson
Organization: Eastern Virginia Medical School
phone: (757)446-7976
e-mail: parsonhk@evms.edu



Responsible Party: Aaron I. Vinik, MD, PhD, Eastern Virginia Medical School
ClinicalTrials.gov Identifier: NCT00931879     History of Changes
Other Study ID Numbers: LVZ111903
Study First Received: June 17, 2009
Results First Received: February 4, 2016
Last Updated: March 28, 2017