NCT03871556

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

February 12, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

March 12, 2019

Completed
8 days until next milestone

Study Start

First participant enrolled

March 20, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 2, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 2, 2022

Completed
12 months until next milestone

Results Posted

Study results publicly available

September 28, 2023

Completed
Last Updated

September 28, 2023

Status Verified

September 1, 2023

Enrollment Period

3.5 years

First QC Date

February 12, 2019

Results QC Date

September 6, 2023

Last Update Submit

September 6, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Difference in Thickness of Subcutaneous Fat at Different Anatomic Sites on the Body

    Will use diagnostic ultrasound to measure fat thickness

    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)

    through study completion, 1 day

Study Arms (1)

Experimental Group

EXPERIMENTAL
Diagnostic Test: LOGIQ P6 Diagnostic Ultrasound

Interventions

Ultrasound measurements of subcutaneous fat thickness

Experimental Group

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Department of Dermatology

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

Title
Dr. Murad Alam
Organization
Northwestern University

Study Officials

  • Murad Alam, MD

    Northwestern University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 12, 2019

First Posted

March 12, 2019

Study Start

March 20, 2019

Primary Completion

October 2, 2022

Study Completion

October 2, 2022

Last Updated

September 28, 2023

Results First Posted

September 28, 2023

Record last verified: 2023-09

Locations