NCT01242020

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2011

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2010

Completed
25 days until next milestone

First Posted

Study publicly available on registry

November 16, 2010

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
6.3 years until next milestone

Results Posted

Study results publicly available

August 10, 2017

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

4 months

First QC Date

October 22, 2010

Results QC Date

July 13, 2017

Last Update Submit

August 10, 2017

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues

    up to 30 days

Study Arms (2)

Lean Healthy Subjects

OTHER

"Lean" defined as (BMI ≥18 and ≤25)

Drug: Perflutren Lipid Microsphere Injectable Suspension

Obese Healthy Subjects

OTHER

Obese grade I-II defined as (BMI\>30 and ≤35)

Drug: Perflutren Lipid Microsphere Injectable Suspension

Interventions

Perflutren Lipid Microsphere Injectable SuspensionDRUG

1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used

Lean Healthy SubjectsObese Healthy Subjects

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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).
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical and Translational Research Center

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination (not feasible with available equipment) leading to small number of subjects analyzed.

Results Point of Contact

Title
Muredach P. Reilly, MBBCh, MSCE
Organization
Associate Dean for Clinical and Translational Research, College of Physicians and Surgeons
mpr2144@cumc.columbia.edu
212-305-9453

Study Officials

  • Muredach P Reilly, MB, MSCE

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

  • Luis H. Eraso, MD, MPH

    University of Pennsylvania

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 22, 2010

First Posted

November 16, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 11, 2017

Results First Posted

August 10, 2017

Record last verified: 2017-08

Locations

US(1)