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Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

Primary Purpose

Lipid Metabolism Disorders, Metabolic Disease

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
CoolSculpting® System
Sponsored by
Federal University of Minas Gerais
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Lipid Metabolism Disorders focused on measuring CoolSculpting, adipose tissue, cryolipolysis, browning

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Departamento de Nutrição Escola de Enfermagem Universidade Federal de Minas Gerais

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CoolSculpting® System

Arm Description

A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage

Outcomes

Primary Outcome Measures

Adipose tissue biology
Fat cell death after cooling by cryolipolysis
Change in volume of fat from baseline
To evaluate change in volume of fat after CoolSculpting treatment(s) using ultrasound and photography.

Secondary Outcome Measures

Decrease in abdominal circumference
decreased abdominal circumference after death of adipocytes
Browning of white adipose tissue
browning of white adipose tissue

Full Information

First Posted
March 24, 2021
Last Updated
March 24, 2021
Sponsor
Federal University of Minas Gerais
Collaborators
Allergan Sales, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04819321
Brief Title
Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
Official Title
Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2021 (Anticipated)
Primary Completion Date
March 1, 2022 (Anticipated)
Study Completion Date
March 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Minas Gerais
Collaborators
Allergan Sales, LLC

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lipid Metabolism Disorders, Metabolic Disease
Keywords
CoolSculpting, adipose tissue, cryolipolysis, browning

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI> 24.9 kg / m² and <30.0 kg / m²).
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CoolSculpting® System
Arm Type
Experimental
Arm Description
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
Intervention Type
Device
Intervention Name(s)
CoolSculpting® System
Intervention Description
A treatment is comprised of timed segments of cooling and heating; a vacuum treatment may include an optional massage
Primary Outcome Measure Information:
Title
Adipose tissue biology
Description
Fat cell death after cooling by cryolipolysis
Time Frame
3 days after the procedure
Title
Change in volume of fat from baseline
Description
To evaluate change in volume of fat after CoolSculpting treatment(s) using ultrasound and photography.
Time Frame
60 days after the procedure
Secondary Outcome Measure Information:
Title
Decrease in abdominal circumference
Description
decreased abdominal circumference after death of adipocytes
Time Frame
60 days after the procedure
Title
Browning of white adipose tissue
Description
browning of white adipose tissue
Time Frame
3 days after the procedure
Other Pre-specified Outcome Measures:
Title
Paradoxical adipose hyperplasia
Description
In case of occurrence of paradoxical adipose hyperplasia after the procedure, a case study of the possible affected patients will be carried out
Time Frame
Up to 60 days after the procedure

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adaliene VM Ferreira, PhD
Phone
+553134093680
Email
adaliene@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mariele L Silva, Master
Email
nutricionistamariele@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariele L Silva, Master
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Amanda CC Oliveira, Master
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adma M Babetto, Student
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Adaliene VM Ferreira, PhD
Organizational Affiliation
Federal University of Minas Gerais
Official's Role
Principal Investigator
Facility Information:
Facility Name
Departamento de Nutrição Escola de Enfermagem Universidade Federal de Minas Gerais
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
30130-100
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
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Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

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