Status:
TERMINATED
Microvascular Flow Assessment Repeatability Study: The MARS Study
Lead Sponsor:
University of Pennsylvania
Conditions:
Obesity
Eligibility:
All Genders
18-45 years
Phase:
NA
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 t...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2011
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01242020
Start Date
January 1 2011
End Date
May 1 2011
Last Update
August 11 2017
Active Locations (1)
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1
Clinical and Translational Research Center
Philadelphia, Pennsylvania, United States, 19104