Subcutaneous FatNCT03871556

Diagnostic Ultrasound for Measuring Fat of the Body

A study testing LOGIQ P6 Diagnostic Ultrasound in people with Subcutaneous Fat, run by Northwestern University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this study is to provide information about human subcutaneous fat thickness at different anatomic sites on the body by measuring these thicknesses with a diagnostic ultrasound and also by correlating patient perceptions of body image with measured fat distribution. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Subcutaneous Fat
What is being tested?: LOGIQ P6 Diagnostic Ultrasound
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 20 Mar 2019to 2 Oct 2022
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 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Males or females 18-85 years old.
Subjects are in good health as judged by the investigator.
Subjects with Body Mass Index (BMI) between 18-29.99.
Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator

Who cannot join

Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
Pregnant or breast feeding
Uncooperative patients or patients with neurological disorders who are incapable of following directions
Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients)

Trial locations and contacts

1 site in 1 country.

United States1 site

Northwestern University Department of Dermatology
Chicago, Illinois, 60611

Other trials in United States

About this study

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Conditions: Subcutaneous Fat
Being tested: LOGIQ P6 Diagnostic Ultrasound

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

LOGIQ P6 Diagnostic UltrasoundDiagnostic test
Ultrasound measurements of subcutaneous fat thickness

Study groups in NCT03871556
Study group	Role	What they receive
Experimental Group	Experimental	Not described Receives: Diagnostic Test: LOGIQ P6 Diagnostic Ultrasound

What is being measured

The primary outcome is the main question the study is designed to answer.

Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body
Will use diagnostic ultrasound to measure fat thickness
Measured: through study completion, 1 day
Gender Differences on Patient Perceptions of Body Image With Measured Fat Distribution
Will use diagnostic ultrasound to measure fat thickness and a questionnaire to assess subject perceptions of their body using a 10-point Likert scale (1= very unsatisfied, 10= very satisfied)
Measured: through study completion, 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Mar 20192 Oct 2022

First posted12 Mar 2019
Study start20 Mar 2019
Primary completion2 Oct 2022
Study completion2 Oct 2022

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 Subcutaneous FatStudies of the same condition, open and under way.
More trials run by Northwestern UniversityThe 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: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03871556
Sponsor's protocol ID: STU002089391
Status last verified: Sep 2023
First submitted: 12 Feb 2019
Last updated: 28 Sep 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 3
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
RecruitingObservational study
Sonographic Thigh Adjustment Ratio and Subcutaneous Fat Thickness as Predictors of Genicular Nerve Block Response in Knee Osteoarthritis
Knee Osteoarthritis, Chronic Knee Pain
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat

All Subcutaneous Fat trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Diagnostic Ultrasound for Measuring Fat of the Body
ClinicalTrials.gov ID: NCT03871556
Acronym / sponsor ID: STU002089391
Conditions: Subcutaneous Fat
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Northwestern UniversityUniversity, hospital or other
Study start: 20 Mar 2019 (actual)
Primary completion: 2 Oct 2022 (actual)
Study completion: 2 Oct 2022 (actual)
First posted: 12 Mar 2019 (actual)
Results: Posted 28 Sep 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Subjects currently living in the Chicago metropolitan area and meet inclusion/exclusion criteria will be considered for enrollment.

Study design

Primary purpose: Diagnosis
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Experimental Group	Experimental	Diagnostic Test: LOGIQ P6 Diagnostic Ultrasound

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Males or females 18-85 years old.
Subjects are in good health as judged by the investigator.
Subjects with Body Mass Index (BMI) between 18-29.99.
Subjects who are willing and have the ability to understand and provide informed consent for participation in the study and are able to communicate with the investigator

Key exclusion criteria (4 listed)

Evidence of another skin condition affecting the treatment area that would interfere with clinical assessments
Pregnant or breast feeding
Uncooperative patients or patients with neurological disorders who are incapable of following directions
Subjects who are unable to understand the protocol or give informed consent (including non-English speaking patients)

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
LOGIQ P6 Diagnostic UltrasoundUltrasound measurements of subcutaneous fat thickness	Diagnostic test	Experimental Group

Primary outcome

Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body
Time frame: through study completion, 1 day
Will use diagnostic ultrasound to measure fat thickness
Gender Differences on Patient Perceptions of Body Image With Measured Fat Distribution
Time frame: through study completion, 1 day
Will use diagnostic ultrasound to measure fat thickness and a questionnaire to assess subject perceptions of their body using a 10-point Likert scale (1= very unsatisfied, 10= very satisfied)

Results and safety

Results posted to the registry on 28 Sep 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Group	40	40

Primary outcome: Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body

Time frame: through study completion, 1 day. Mean (Standard Deviation). Unit: average fat measurement (cm)

Measure	Male n = 18	Female n = 22
Chin	.56 (.27)	.60 (.14)
Left arm	.83 (.59)	1.65 (.57)
Right arm	.82 (.51)	1.72 (.58)
Left back	.77 (.44)	1.30 (.45)
Right back	.86 (.51)	1.20 (.52)
Left flank	1.31 (.58)	1.81 (.47)
Right flank	1.16 (.55)	1.83 (.47)
Abdomen	1.71 (.70)	2.19 (.61)

Primary outcome: Gender Differences on Patient Perceptions of Body Image With Measured Fat Distribution

Time frame: through study completion, 1 day. Mean (Standard Deviation). Unit: average satisfaction level

Measure	Male n = 18	Female n = 22
Chin	8.48 (1.38)	5.14 (3.47)
Inner arms	7.41 (2.45)	4.02 (3.22)
Upper back	7.90 (1.91)	5.18 (2.81)
Flanks	6.48 (2.6)	3.45 (2.97)
Abdomen	5.98 (2.71)	2.93 (3.12)
Inner thigh	7.58 (2.12)	5.04 (3.62)
Outer thigh	7.91 (2.25)	5.93 (3.15)
Overall	7.28 (2.13)	4.70 (2.24)

Adverse events

Time frame: One 3 hour session on 1 day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Group	0 of 40 (0%)	0 of 40 (0%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Subcutaneous Fat

RecruitingPhase 3
Efficacy and Safety of Mibavademab in Adult and Pediatric Patients With Generalized Lipodystrophy
Generalized Lipodystrophy
Active, not recruitingPhase 1/2
A Trial to Learn How Safe AZD9550 Monotherapy and Combined With AZD6234 is in People With or Without Type 2 Diabetes Who Are Living With Obesity and Overweight
Overweight and Obesity
Not yet recruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat
RecruitingObservational study
Sonographic Thigh Adjustment Ratio and Subcutaneous Fat Thickness as Predictors of Genicular Nerve Block Response in Knee Osteoarthritis
Knee Osteoarthritis, Chronic Knee Pain
RecruitingPhase 2
A Study to Evaluate the Efficacy, Safety, and Tolerability of CBL-514 Injection for Reducing Abdominal Subcutaneous Fat
Subcutaneous Fat

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.

Murad Alam, MD principal investigator

Northwestern University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing LOGIQ P6 Diagnostic Ultrasound in people with Subcutaneous Fat, run by Northwestern University 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 4 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: finished, as of the sponsor's last update on 28 Sep 2023. 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 28 Sep 2023). 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?

Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body (time frame: through study completion, 1 day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03871556.

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 28 Sep 2023.