NCT03160976

Brief Summary

The aim of this study is to analyze the effects of a single session of cryolipolysis on localized adiposity on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomly allocated into two groups: Control Group or Intervention Group. The following assessments will be performed in both groups: ultrasonography and body composition at baseline and 30, 60 and 90 days after randomization and blood analysis at baseline and 15 and 30 days after randomization. The expected main result at the end of this study is the reduction of the local subcutaneous fat tissue.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 16, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2017

Completed
6 days until next milestone

Study Start

First participant enrolled

May 25, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 25, 2017

Completed
Last Updated

May 24, 2017

Status Verified

May 1, 2017

Enrollment Period

3 months

First QC Date

May 16, 2017

Last Update Submit

May 22, 2017

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (1)

  • Subcutaneous fat layer

    Subcutaneous fat layer changes measured by ultrasonography and skinfold.

    Baseline, 30, 60 and 90 days after intervention.

Secondary Outcomes (11)

  • Abdominal circumference

    Baseline, 30, 60 and 90 days after intervention.

  • Inflammatory profile

    Baseline, 15 and 30 days after intervention.

  • Body fat mass

    Baseline, 30, 60 and 90 days after intervention.

  • Liver function

    Baseline, 15 and 30 days after intervention.

  • Kidney function

    Baseline, 15 and 30 days after intervention.

  • +6 more secondary outcomes

Study Arms (2)

Control Group

NO INTERVENTION

Subjects will only receive the Evaluation Protocol and will be followed for 90 days.

Intervention Group

ACTIVE COMPARATOR

A single 50 minutes session of cold exposure with a cryolipolysis device. The parameters will be: temperature -10°C and vacuum between 60 Kpas (at beginning) and 40 Kpas (until the end).

Other: Cryolipolysis

Interventions

CryolipolysisOTHER

First, the demarcation of the lower abdomen area at the same landmarks of the ultrasonography will be done. Secondly, the patient will be positioned on the stretcher in the supine position with a 45 ° elevation of the trunk. In this position, to protect the region to be treated, a glycerine antifreeze membrane will be placed. The treatment parameters will be: temperature of -10 ° C, treatment time of 50 minutes (first 3 minutes of heating at 42°C) and moderate vacuum pressure (60 - 40 Kpas). The applicator will be chosen according to the size of the area of each subject and positioned in the target region. At the end the skinfold will be released automatically, the antifreeze membrane removed and a manual massage will be carried out for five minutes to stimulate local blood reperfusion.

Intervention Group

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Age 18 to 45 or not being on menopause
  • Sedentary according to International Physical Activity Questionnaire
  • Body Mass Index lower than 27 Kg/m²
  • Skinfold: more than 3 centimeters at the lower abdomen

You may not qualify if:

  • Cryoglobulinemia
  • Cold urticaria
  • Paroxysmal cold hemoglobinuria
  • Raynaud disease
  • Pregnancy and Breastfeeding
  • Cancer
  • Vascular diseases
  • Heart diseases
  • Epidermal lesions at the site of application
  • Autoimmune diseases
  • Osteoporosis
  • Metallic implants and pacemaker
  • Alterations of sensibility
  • Inflammatory process and active infection
  • Abdominal hernia
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Federal University of Health Science of Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050170, Brazil

Location

Related Publications (1)

  • Falster M, Schardong J, Santos DPD, Machado BC, Peres A, Rosa PVD, Plentz RDM. Effects of cryolipolysis on lower abdomen fat thickness of healthy women and patient satisfaction: a randomized controlled trial. Braz J Phys Ther. 2020 Sep-Oct;24(5):441-448. doi: 10.1016/j.bjpt.2019.07.005. Epub 2019 Jul 26.

    PMID: 31375459DERIVED

Study Officials

  • Rodrigo DM Plentz, PhD

    Federal University of Health Science of Porto Alegre

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rodrigo DM Plentz, PhD

CONTACT

55 51 91131651roplentz@yahoo.com.br

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 16, 2017

First Posted

May 19, 2017

Study Start

May 25, 2017

Primary Completion

August 25, 2017

Study Completion

October 25, 2017

Last Updated

May 24, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)