Microvascular Flow Assessment Repeatability Study: The MARS Study

Study Overview
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Brief Summary
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The purpose of this study is to test a method of imaging (taking a picture) of the abdomen (belly), neck, thigh and calf (lower leg) areas of the body, using ultrasound along with a drug which makes the pictures look clearer. Ultrasound is a type of imaging that uses sound waves to create a picture of the inside of the human body. Two sets of pictures will be taken on two different days to see if the results are the same each time. DEFINITY® is a drug given intravenously (through the vein). DEFINITY® is approved by the FDA to be used as an ultrasound contrast agent (makes the pictures look clearer) while taking pictures of the heart. In this study, DEFINITY® will be used while taking pictures of blood vessels in your abdomen (belly), neck, thigh and calf (lower leg). Since this use of DEFINITY® is different than the use approved by the FDA, this study will be performed under an FDA Investigational New Drug (IND) application.

Official Title
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Microvascular Flow Assessment of the Periadventitial Adipose Tissue, Subcutaneous Adipose Tissue and Skeletal Muscle Using Contrast Enhanced Ultrasound (CEU); A Repeatability Study

Conditions
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Obesity

Intervention / Treatment
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* Drug: Perflutren Lipid Microsphere Injectable Suspension


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and non-pregnant/lactating women between the ages of 18 and 45; Lean (BMI ≥18 and ≤25) or Obese grade I-II(BMI>30 and ≤35) Provide written informed consent and sign HIPAA Waiver of Authorization Be able and willing to follow all instructions and attend all study visits Exclusion Criteria: Subjects must not have been diagnosed with: Coronary artery disease Congestive heart failure Congenital heart disease (Right-to-left, bi-directional, or transient right-to-left cardiac shunts) Hypersensitivity to perflutren Renal disease Chronic obstructive pulmonary disease or Asthma Primary or secondary pulmonary hypertension Obstructive sleep apnea Thyroid disease Vasculitis Peripheral arterial disease. Cancer Any type of immunosuppression Any active infection (systemic or of the underlying skin or subcutaneous tissue). Taking any prescribed medication for hypertension, dyslipidemia or diabetes. Current or past smoking in the last 12 months. Positive urine pregnancy test Creatinine (Cr) above 1.4 mg/dl on screening evaluation Hemoglobin (Hb) less than 10 mg/dl on screening evaluation Aspartate Transaminase (AST) or Alanine Transaminase (ALT) two fold above upper limit of normal on screening evaluation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Lean Healthy Subjects<br>Lean defined as (BMI ≥18 and ≤25) | Drug: Perflutren Lipid Microsphere Injectable Suspension<br>* 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used<br>|
| Other: Obese Healthy Subjects<br>Obese grade I-II defined as (BMI>30 and ≤35) | Drug: Perflutren Lipid Microsphere Injectable Suspension<br>* 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of Repeated Measures for Each Subject | The variability of repeated measures for each subject, expressed as coefficient of variation (CV), in the periadventitial microvascular flow, subcutaneous microvascular flow and skeletal muscle flow. | up to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues |  | up to 30 days |