Microvascular Flow Assessment Repeatability Study: The MARS Study

Obesity Clinical Trial

— MARS  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01242020
• Other study ID #: 811310
• Status: Terminated
• Phase: N/A
• First received: October 22, 2010
• Last updated: August 10, 2017
• Start date: January 2011
• Est. completion date: May 2011

Study information

• Verified date: August 2017
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 6
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Drug:
• Perflutren Lipid Microsphere Injectable Suspension
1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

Locations

Country	Name	City	State
United States	Clinical and Translational Research Center	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	up to 30 days
Secondary	Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues		up to 30 days