Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans

NCT04819321 | Unknown FDA Device

• 1 other identifier: 30339520.8.0000.5149
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Lipid Metabolism Disorders; Metabolic Disease

Keywords

CoolSculpting; adipose tissue; cryolipolysis; browning

Outcome Measures

Primary Outcomes (2)

• Adipose tissue biology

  Fat cell death after cooling by cryolipolysis

  3 days after the procedure

• Change in volume of fat from baseline

  To evaluate change in volume of fat after CoolSculpting treatment(s) using ultrasound and photography.

  60 days after the procedure

Secondary Outcomes (2)

• Decrease in abdominal circumference

  60 days after the procedure

• Browning of white adipose tissue

  3 days after the procedure

Other Outcomes (1)

• Paradoxical adipose hyperplasia

  Up to 60 days after the procedure

Study Arms (1)

CoolSculpting® System

EXPERIMENTAL

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

Device: CoolSculpting® System

Interventions

CoolSculpting® System DEVICE

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

CoolSculpting® System

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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 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.

Sponsors & Collaborators

• Federal University of Minas Gerais: lead
• Allergan Sales, LLC: collaborator

Study Sites (1)

Departamento de Nutrição Escola de Enfermagem Universidade Federal de Minas Gerais

Belo Horizonte, Minas Gerais, 30130-100, Brazil

Location

Related Publications (18)

• Agrawal M, Kern PA, Nikolajczyk BS. The Immune System in Obesity: Developing Paradigms Amidst Inconvenient Truths. Curr Diab Rep. 2017 Aug 15;17(10):87. doi: 10.1007/s11892-017-0917-9.

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• Aldiss P, Betts J, Sale C, Pope M, Budge H, Symonds ME. Exercise-induced 'browning' of adipose tissues. Metabolism. 2018 Apr;81:63-70. doi: 10.1016/j.metabol.2017.11.009. Epub 2017 Nov 16.

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• Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864.

  PMID: 20014262 BACKGROUND

• Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014 Feb;46(2):75-80. doi: 10.1002/lsm.22207. Epub 2013 Dec 3.

  PMID: 24535759 BACKGROUND

• Harms M, Seale P. Brown and beige fat: development, function and therapeutic potential. Nat Med. 2013 Oct;19(10):1252-63. doi: 10.1038/nm.3361. Epub 2013 Sep 29.

  PMID: 24100998 BACKGROUND

• Ingargiola MJ, Motakef S, Chung MT, Vasconez HC, Sasaki GH. Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms. Plast Reconstr Surg. 2015 Jun;135(6):1581-1590. doi: 10.1097/PRS.0000000000001236.

  PMID: 26017594 BACKGROUND

• Kajimura S, Spiegelman BM, Seale P. Brown and Beige Fat: Physiological Roles beyond Heat Generation. Cell Metab. 2015 Oct 6;22(4):546-59. doi: 10.1016/j.cmet.2015.09.007.

  PMID: 26445512 BACKGROUND

• Kilmer SL. Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.

  PMID: 27327898 BACKGROUND

• Kilmer SL, Burns AJ, Zelickson BD. Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat. Lasers Surg Med. 2016 Jan;48(1):3-13. doi: 10.1002/lsm.22440. Epub 2015 Nov 26.

  PMID: 26607045 BACKGROUND

• Krueger N, Mai SV, Luebberding S, Sadick NS. Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction. Clin Cosmet Investig Dermatol. 2014 Jun 26;7:201-5. doi: 10.2147/CCID.S44371. eCollection 2014.

  PMID: 25061326 BACKGROUND

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MeSH Terms

Conditions

Lipid Metabolism Disorders; Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Officials

• 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

  STUDY CHAIR

• Adaliene VM Ferreira, PhD

  Federal University of Minas Gerais

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adaliene VM Ferreira, PhD

CONTACT

+553134093680; adaliene@gmail.com

Mariele L Silva, Master

CONTACT

nutricionistamariele@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adaliene Versiani M. Ferreira, PHD

Model Details: The sample will comprise 12 adult women (aged 18 to 40 years) and overweight (BMI\> 24.9 kg / m² and \<30.0 kg / m²).

Study Record Dates

• First Submitted: March 24, 2021
• First Posted: March 26, 2021
• Study Start: April 1, 2021
• Primary Completion: March 1, 2022
• Study Completion: March 1, 2022
• Last Updated: March 26, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)