Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

March 24, 2021 updated by: Adaliene Versiani M. Ferreira, Federal University of Minas Gerais
The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²). The experimental design will consist of four assessments. In the first assessments a structured questionnaire will be applied to obtain health and food consumption data, in addition to evaluate anthropometric (weight, height, waist and hip circumference), and collection of blood. In addition, an ultrasound examination, digital photography and biopsy of the subcutaneous WAT, of the abdominal region, will be performed. After 30 day subjects will undergo CoolSculpting treatment(s) in an outpatient clinical setting. The treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage. Treatments will be administered according to the User Manual CoolSculpting System. The volunteers will return for the biopsy of the subcutaneous WAT, from the abdominal region, in 3 days after the procedure. In 4º assessment, 60 days after cryolipolysis, all evaluations performed in the first assessment will be repeated and to evaluate overall patient satisfaction for non-invasive fat reduction in CoolSculpting subjects.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

This is a longitudinal, non-randomized clinical trial to assess the biology of AT after the use of cryolipolysis. The study will be developed at "Clinica Dra Ligia Colucci" in partnership with the Federal University of Minas Gerais (UFMG). The project will be submitted for evaluation by the Research Ethics Committee (COEP / UFMG). All participants must sign the informed consent form (ICF), before the study begins.

The experimental design will consist of five stages. Initially, women will be public recruitment. Through telephone contact, the inclusion and exclusion criteria will be verified, and volunteers who meet the criteria will be invited to attend the clinic for the first stage of the study. The presentation of the research, will be carried out 7 days before the beginning of the treatment, will consist of presenting the project to the volunteers, explaining all the risks and benefits related to the study and request the signature of the ICF. After 7 days, the volunteers must return to the clinic, then start the study. In the initial evaluation, an anamnesis of the volunteers will be carried out with a standardized form, including socioeconomic and clinical data, data on the use of medications, alcohol consumption, physical activity and food consumption. In addition, anthropometric assessments will be performed where weight, height, waist, abdominal and hip circumference will be measured. Ultrasonography will also be performed; the abdominal region will be photographed and blood will be collected to measure lipolytic and inflammatory markers and a biopsy of the subcutaneous WAT in the lower abdomen via umbilical scar. In addition, questionnaires will be applied to check the volunteers' satisfaction with the treatment. After 30 days, the volunteers must return to the clinic for time 0 (T0), where anthropometric assessments will be repeated as control variables. Ultrasound and blood collection will also be performed. Then the volunteers will be submitted to cryolipolysis in the abdominal region by the Coolsculpting® system. After 3 days of performing the Coolsculpting® procedure, the volunteers must return to the clinic for time 3 (T3), to perform a new biopsy of the subcutaneous WAT in the lower abdomen via the umbilical scar. After 60 days of the cryolipolysis, the volunteers must return to the clinic for the time 60 (T60), where all the evaluations of the initial evaluation will be carried out again and a personal satisfaction questionnaire will be applied in relation to the result of the procedure. Therefore, the study will total 97 days of monitoring of women, who will be instructed to maintain healthy lifestyle habits, according to the conventional lifestyle of each one of them. The data, images and biological materials (blood and adipose tissue biopsy) collected in the research will be filed with the researcher responsible for a period of 5 (five) years at the Experimental Nutrition Laboratory, room 315, of the UFMG School of Nursing and after that time will be destroyed. In case of occurrence of paradoxical adipose hyperplasia after the procedure, a case study of the possible affected patients will be carried out.

Study Type

Interventional

Enrollment (Anticipated)

12

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • MG
      • Belo Horizonte, MG, Brazil, 30130-100
        • Departamento de Nutrição Escola de Enfermagem Universidade Federal de Minas Gerais

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Subject has clearly visible fat in the flanks and/or abdomen, which in the investigator's opinion, may benefit from the treatment.

Subject has not had weight change fluctuations exceeding 4.5 kg (or 5% of body weight) in the preceding month.

Subject has a BMI of 24.9 to 30. A BMI is defined as weight in kilograms divided by height in meters squared (kg/m2).

Subject agrees to maintain weight (ie, within 5% of body weight) by not making any changes in diet or exercise routine during the course of the study.

Subject agrees to have photographs taken of the treatment area(s) during the scheduled time periods.

Exclusion Criteria:

  • Subject has had liposuction, or another surgical procedure(s) or mesotherapy in area of intended treatment.

Subject has had a non-invasive fat reduction and/or body contouring procedure in the area(s) of intended treatment within the past 12 months.

Subject needs to administer, or has a known history of subcutaneous injections into the area(s) of intended treatment (eg, cortisone, heparin, insulin) within the past 6 months.

Subject is pregnant or intending to become pregnant. Subject is lactating or has been lactating in the past 6-9 months. Subject is unable or unwilling to comply with study requirements. Subject is currently enrolled in a clinical study of any unapproved investigational device, investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.

Subject has an active implanted device such as a pacemaker, defibrillator, or drug delivery system or any other metal containing implant.

Subject with known history of cryoglobulinemia, cold agglutinin disease, or paroxysmal cold hemoglobinuria.

Subject with known sensitivity to cold or has any condition with a known response to cold exposure that limits blood flow to the skin such as cold urticaria or Raynaud's disease, or Chilblains (pernio).

Subject with known sensitivity or allergy to fructose, glycerin, isopropyl alcohol, or propylene glycol.

Subject with impaired peripheral circulation in the area to be treated Subject with neuropathic disorders such as post-herpetic neuralgia or diabetic neuropathy.

Subject with impaired skin sensation. Subject with open or infected wounds. Subject with bleeding disorders, or concomitant use of blood thinners, or is taking any medication that in the investigator's opinion may increase the subject's risk of bruising.

Subject with recent surgery or scar tissue in the area to be treated. Subject has history of hernia in or adjacent to the treatment area(s) site. Subject with skin conditions such as eczema, dermatitis, or rashes in the area to be treated.

Subject has any dermatological conditions, such as moderate to excessive skin laxity, or scars in the location of the treatment sites that may interfere with the treatment or evaluation (stretch marks is not an exclusion).

Subject is taking or has taken diet pills or supplements within the past 6 months.

Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Subject diagnosed with fibrosis.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CoolSculpting® System
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
Device: CoolSculpting® System
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adipose tissue biology
Time Frame: 3 days after the procedure
Fat cell death after cooling by cryolipolysis
3 days after the procedure
Change in volume of fat from baseline
Time Frame: 60 days after the procedure
To evaluate change in volume of fat after CoolSculpting treatment(s) using ultrasound and photography.
60 days after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Decrease in abdominal circumference
Time Frame: 60 days after the procedure
decreased abdominal circumference after death of adipocytes
60 days after the procedure
Browning of white adipose tissue
Time Frame: 3 days after the procedure
browning of white adipose tissue
3 days after the procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Paradoxical adipose hyperplasia
Time Frame: Up to 60 days after the procedure
In case of occurrence of paradoxical adipose hyperplasia after the procedure, a case study of the possible affected patients will be carried out
Up to 60 days after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Minas Gerais

Collaborators

Allergan Sales, LLC

Investigators

  • Study Chair: Mariele L Silva, Master, Federal University of Minas Gerais
  • Study Chair: Amanda CC Oliveira, Master, Federal University of Minas Gerais
  • Study Chair: Adma M Babetto, Student, Federal University of Minas Gerais

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2021

Primary Completion (Anticipated)

March 1, 2022

Study Completion (Anticipated)

March 1, 2022

Study Registration Dates

First Submitted

March 24, 2021

First Submitted That Met QC Criteria

March 24, 2021

First Posted (Actual)

March 26, 2021

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 24, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 30339520.8.0000.5149

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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