ObesityMARSNCT01242020
Microvascular Flow Assessment Repeatability Study: The MARS Study
A study testing Perflutren Lipid Microsphere Injectable Suspension in people with Obesity, run by University of Pennsylvania at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Perflutren Lipid Microsphere Injectable Suspension
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to May 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Clinical and Translational Research Center
Philadelphia, Pennsylvania, 19104
About this study
Official title: Microvascular Flow Assessment of the Periadventitial Adipose Tissue, Subcutaneous Adipose Tissue and Skeletal Muscle Using Contrast Enhanced Ultrasound (CEU); A Repeatability Study
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.
- Conditions
- Obesity
- Being tested
- Perflutren Lipid Microsphere Injectable Suspension
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Perflutren Lipid Microsphere Injectable SuspensionDrug
1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used
| Study group | Role | What they receive |
|---|---|---|
| Lean Healthy Subjects | Other | "Lean" defined as (BMI ≥18 and ≤25) Receives: Drug: Perflutren Lipid Microsphere Injectable Suspension |
| Obese Healthy Subjects | Other | Obese grade I-II defined as (BMI>30 and ≤35) Receives: Drug: Perflutren Lipid Microsphere Injectable Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 30 days
Secondary outcomes (1)
Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues
Measured: up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2011
- Study completionMay 2011
Why it stopped: Unable to reliably reproduce, visualize, or quantify microvascular flow in the subcutaneous tissue, the skeletal muscle or peri-adventitia
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muredach P Reilly, MB, MSCE, Principal investigator, University of PennsylvaniaLuis H. Eraso, MD, MPH, Study director, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01242020
- Sponsor's protocol ID
- 811310
- Acronym
- MARS
- Status last verified
- Aug 2017
- First submitted
- 22 Oct 2010
- Last updated
- 11 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Microvascular Flow Assessment of the Periadventitial Adipose Tissue, Subcutaneous Adipose Tissue and Skeletal Muscle Using Contrast Enhanced Ultrasound (CEU); A Repeatability Study
- ClinicalTrials.gov ID
- NCT01242020
- Acronym / sponsor ID
- MARS / 811310
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to reliably reproduce, visualize, or quantify microvascular flow in the subcutaneous tissue, the skeletal muscle or peri-adventitia
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Jan 2011 (actual)
- Primary completion
- May 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 16 Nov 2010 (estimated)
- Results
- Posted 10 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean Healthy Subjects | Other | Drug: Perflutren Lipid Microsphere Injectable Suspension"Lean" defined as (BMI ≥18 and ≤25) |
| Obese Healthy Subjects | Other | Drug: Perflutren Lipid Microsphere Injectable SuspensionObese grade I-II defined as (BMI>30 and ≤35) |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Perflutren Lipid Microsphere Injectable Suspension1.3 mL activated DEFINITY® diluted in 50 mL of preservative-free saline will be used | Drug | Lean Healthy Subjects, Obese Healthy Subjects |
Primary outcome
Variability of Repeated Measures for Each Subject
Time frame: 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.
1 secondary outcome
Microvascular Flow in the Periadventitial, Subcutaneous and Skeletal Muscle Tissues
Time frame: up to 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muredach P Reilly, MB, MSCE principal investigator
University of Pennsylvania
Luis H. Eraso, MD, MPH study director
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Perflutren Lipid Microsphere Injectable Suspension in people with Obesity, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Variability of Repeated Measures for Each Subject (time frame: up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2017.