Subcutaneous FatNCT03160976
Cryolipolysis on Localized Adiposity
A study testing Cryolipolysis in people with Subcutaneous Fat, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Subcutaneous Fat
- What is being tested?
- Cryolipolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteBrazil
- Study dates
- 25 May 2017to 25 Oct 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Cryoglobulinemia
- Cold urticaria
- Paroxysmal cold hemoglobinuria
- Raynaud disease
- Pregnancy and Breastfeeding
- Cancer
Show all 21Show fewer
- 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
- Abdominal muscle diastasis
- Diabetes
- Anemia
- Previous plastic surgery on the area
- Liver and kidney diseases
- Cognitive impairment that prevents conducting evaluations, as well as inability to understand and sign the informed consent form
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Health Science of Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050170
Rodrigo DM Plentz, PhD, 55 51 998419044, roplentz@yahoo.com.br
About this study
Official title: Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial
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.
Read the detailed description
Cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. Although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. Then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomized to Control Group (CG) or Intervention Group (IG). The CG will perform the Evaluation Protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. The IG will receive a single cryolipolysis's session on lower abdomen and the Evaluation Protocol. The follow up for both groups is 90 days. Expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.
- Conditions
- Subcutaneous Fat
- Being tested
- Cryolipolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Other: Cryolipolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subcutaneous fat layer
Subcutaneous fat layer changes measured by ultrasonography and skinfold.
Measured: Baseline, 30, 60 and 90 days after intervention.
Secondary outcomes (11)
Abdominal circumference
Abdominal circumference changes measured by perimetry method.
Measured: Baseline, 30, 60 and 90 days after intervention.
Inflammatory profile
Inflammatory profile analyzed through level of interleukin - 6, tumor necrosis factor - alfa, monocyte chemotactic protein-1 and leptin.
Measured: Baseline, 15 and 30 days after intervention.
Body fat mass
Body fat mass changes measured by bioimpedance.
Measured: Baseline, 30, 60 and 90 days after intervention.
Liver function
Liver function analyzed through aspartate aminotransferase and alanine aminotransferase
Measured: Baseline, 15 and 30 days after intervention.
Kidney function
Kidney function analyzed through creatinine and urea
Measured: Baseline, 15 and 30 days after intervention.
Lipids profile
Lipids profile analyzed through high density lipoprotein, low density lipoprotein, cholesterol, triglycerides and glucose levels.
Measured: Baseline, 15 and 30 days after intervention
Local temperature
Local temperature changes with cryolipolysis measured by thermographic analysis.
Measured: 2 minutes before and 2 minutes after intervention and massage
Adverse effects
Identification of possible adverse effects by patient report
Measured: 15 days after intervention
Pain level
Pain level measured by analogue visual pain scale
Measured: First minute, twenty-fifth minute, fiftieth minute after intervention and first minute during the massage
Body weight and body mass index
Body weight and body mass index
Measured: Baseline, 30, 60 and 90 days after intervention.
Physical Activity
Level of physical activity measured by the International Physical Activity Questionnaire
Measured: Baseline and every 15 days after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2017
- Study start25 May 2017 (estimated)
- Primary completion25 Aug 2017 (estimated)
- Study completion25 Oct 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Subcutaneous FatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Health Science of Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rodrigo Della Méa Plentz, Federal University of Health Science of Porto Alegre
- Investigators
- Rodrigo DM Plentz, PhD, Principal investigator, Federal University of Health Science of Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03160976
- Sponsor's protocol ID
- ECLA2017
- Status last verified
- May 2017
- First submitted
- 16 May 2017
- Last updated
- 24 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31375459
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Cryolipolysis on Localized Adiposity: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03160976
- Acronym / sponsor ID
- ECLA2017
- Conditions
- Subcutaneous Fat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Federal University of Health Science of Porto AlegreUniversity, hospital or other
- Study start
- 25 May 2017 (estimated)
- Primary completion
- 25 Aug 2017 (estimated)
- Study completion
- 25 Oct 2017 (estimated)
- First posted
- 19 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Cryolipolysis is a non - invasive method for localized fat reduction wich uses low temperatures to induce an apoptotic and inflammatory response and consequent adipocyte death in the treated area. Although the practice of this technique has been increasing, there are some gaps in the literature about the exact mechanism of action and only a few randomized clinical trials that proves its effectiveness and safety. Then, the aim of this study is to analyse the effects of cryolipolysis on localized fat on women's abdomen. This is a randomized controlled clinical trial that will include 28 women who will be randomized to Control Group (CG) or Intervention Group (IG). The CG will perform the Evaluation Protocol with the following assessments: ultrasonography, thermographic analysis, blood analysis, bioimpedance and measurement of skinfold and abdominal circumference. The IG will receive a single cryolipolysis's session on lower abdomen and the Evaluation Protocol. The follow up for both groups is 90 days. Expected main result at the end of the study is the reduction of the local subcutaneous fat tissue.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –Subjects will only receive the Evaluation Protocol and will be followed for 90 days. |
| Intervention Group | Active comparator | Other: CryolipolysisA 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). |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (21 listed)
- Cryoglobulinemia
- Cold urticaria
- Paroxysmal cold hemoglobinuria
- Raynaud disease
- Pregnancy and Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryolipolysisFirst, 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. | Other | Intervention Group |
Primary outcome
Subcutaneous fat layer
Time frame: Baseline, 30, 60 and 90 days after intervention.
Subcutaneous fat layer changes measured by ultrasonography and skinfold.
11 secondary outcomes
Abdominal circumference
Time frame: Baseline, 30, 60 and 90 days after intervention.
Inflammatory profile
Time frame: Baseline, 15 and 30 days after intervention.
Body fat mass
Time frame: Baseline, 30, 60 and 90 days after intervention.
Liver function
Time frame: Baseline, 15 and 30 days after intervention.
Kidney function
Time frame: Baseline, 15 and 30 days after intervention.
Lipids profile
Time frame: Baseline, 15 and 30 days after intervention
Local temperature
Time frame: 2 minutes before and 2 minutes after intervention and massage
Adverse effects
Time frame: 15 days after intervention
Pain level
Time frame: First minute, twenty-fifth minute, fiftieth minute after intervention and first minute during the massage
Body weight and body mass index
Time frame: Baseline, 30, 60 and 90 days after intervention.
Physical Activity
Time frame: Baseline and every 15 days after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2017.
- Derived from this study: PubMed 31375459Falster 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rodrigo DM Plentz, PhD principal investigator
Federal University of Health Science of Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cryolipolysis in people with Subcutaneous Fat, run by Federal University of Health Science of Porto Alegre at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rodrigo DM Plentz, PhD (55 51 91131651, roplentz@yahoo.com.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subcutaneous fat layer (time frame: Baseline, 30, 60 and 90 days after intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03160976, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 May 2017.