Obesity
Conditions
Brief summary
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.
Interventions
1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
Sponsors
University of Pennsylvania
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
Inclusion criteria
1. Men and non-pregnant/lactating women between the ages of 18 and 45; 2. Lean (BMI ≥18 and ≤25) or Obese grade I-II(BMI\>30 and ≤35) 3. Provide written informed consent and sign HIPAA Waiver of Authorization 4. Be able and willing to follow all instructions and attend all study visits
Exclusion criteria
Subjects must not have been diagnosed with: 1. Coronary artery disease 2. Congestive heart failure 3. Congenital heart disease (Right-to-left, bi-directional, or transient right-to-left cardiac shunts) 4. Hypersensitivity to perflutren 5. Renal disease 6. Chronic obstructive pulmonary disease or Asthma 7. Primary or secondary pulmonary hypertension 8. Obstructive sleep apnea 9. Thyroid disease 10. Vasculitis 11. Peripheral arterial disease. 12. Cancer 13. Any type of immunosuppression 14. Any active infection (systemic or of the underlying skin or subcutaneous tissue). 15. Taking any prescribed medication for hypertension, dyslipidemia or diabetes. 16. Current or past smoking in the last 12 months. 17. Positive urine pregnancy test 18. Creatinine (Cr) above 1.4 mg/dl on screening evaluation 19. Hemoglobin (Hb) less than 10 mg/dl on screening evaluation 20. Aspartate Transaminase (AST) or Alanine Transaminase (ALT) two fold above upper limit of normal on screening evaluation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Variability of Repeated Measures for Each Subject | up to 30 days | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues | up to 30 days |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lean Healthy Subjects Lean defined as (BMI ≥18 and ≤25)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used | 6 |
| Obese Healthy Subjects Obese grade I-II defined as (BMI\>30 and ≤35)
Perflutren Lipid Microsphere Injectable Suspension: 1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used | 0 |
| Total | 6 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Failed screening | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 0 |
Baseline characteristics
| Characteristic | Lean Healthy Subjects | Obese Healthy Subjects | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants | 0 Participants | 6 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 3 Participants | 0 Participants | 3 Participants |
| Sex: Female, Male Female | 2 Participants | 0 Participants | 2 Participants |
| Sex: Female, Male Male | 4 Participants | 0 Participants | 4 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 0 |
| other Total, other adverse events | 0 / 6 | 0 / 0 |
| serious Total, serious adverse events | 0 / 6 | 0 / 0 |
Outcome results
Primary
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.
Time frame: up to 30 days
Population: Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal microvascular flow were not collected for the Outcome Measure.
Secondary
Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues
Time frame: up to 30 days
Population: Reliable data for periadventitial microvascular flow, subcutaneous microvascular flow, and skeletal muscle microvascular flow were not be collected for this outcome measure.