Cryotherapy and Body Slimming (Cryotherapy)

February 25, 2020 updated by: Clinic Cryo Esthetic

Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags

The purpose of this study is to evaluate the efficacy of cryotherapy on the slimming of subcutaneous fat mass in the abdomen and saddlebags. Cryotherapy is a completely non-invasive method that induces a selective reduction of fat cells by localized and controlled cooling in areas such as the abdomen, flanks, inner knees, inner thighs, back and arms.

Adipose tissue is composed of two types of tissue: white and brown adipose tissue. Studies have shown that exposure to cold induces an increase in the number of brown adipocytes (detected by PET/CT-scan) under the effect of the hormone irisin produced by the muscles. In addition, another study has shown that prolonged exposure to cold reduces the size of brown adipocytes leading to thermogenesis, suggesting that cold exposure may contribute to the control of obesity.

The freezing technology of this cryotherapy unit allows the temperature of the subcutaneous adipose tissue to move almost instantaneously from -6°C to -10°C, gradually causing the reduction of subcutaneous adipose tissue.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Prospective, monocentric pilot and comparative (before and after) study in simple blind (assessor different from the operator).

  • The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the level of the saddlebags.
  • Measurement of subcutaneous fat mass with iDXA scanner on treated areas
  • Metabolic parameters from a blood test: Liver function (AST, ALT, gamma GT), inflammatory markers, plasmatic fatty acids, glycerol, total cholesterol, triglycerides, lipids, blood sugar, insulin, lactate.

Study Type

Interventional

Enrollment (Actual)

30

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 Locations

  • France
      • Paris, France, 75007
        • Cryoesthetic

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 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Patients ≥ 18 years old and non-menopausal with a BMI between 20 and 30 (20≥IMC≤30), with an overload of abdominal subcutaneous fat tissue and at the saddlebags

Exclusion Criteria:

  • - < 18 years old.
  • Pregnancy
  • Breastfeeding
  • Cold allergy: 2-minute ice cube test positive
  • A waist/hip ratio indicative of a pathological fat distribution (>0.8 for women, >0.9 for men)
  • Endocrine pathologies (Cushing's disease, endocrine tumours, unbalanced frank or labile hypothyroidism, hirsutism and hyper-androgenism, insulin resistance and/or unbalanced type 2 diabetes...)
  • Neoplasia
  • Psychiatric pathologies with or without treatment (Antidepressants, Neuroleptics, Anxiolytics...), well characterized anorexia-bulimia syndromes.
  • Established alcoholism. Daily alcohol consumption should not exceed 2 glasses of wine per day.
  • Digestive pathologies (especially hepatic) and functional digestive disorders (chronic constipation, alternating constipation-diarrhoea, chronic abdominal pain).
  • Weaknesses of the abdominal wall (umbilical, inguinal, crural hernias)
  • HIV in therapy
  • Genetic deformities and diseases
  • Vegetarian/vegetarian diet, macrobiotic diet
  • Spasmophilia
  • Surgery less than 3 months old
  • Unbalanced coronary artery disease, untreated angina

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Croytherapy on abdomen and saddlebags
Six (6) to 10 applicators (application area of 17 cm X 6 cm) are applied on the dorsal side (back, waist, saddlebags) for 45 minutes and then on the ventral side (belly) for 45 minutes, with adjustments according to the size of the participant. The temperature applied with the device is variable (-10°c to -7°C).
Device: Cryotherapy on abdomen and saddlebags
Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metric measurements of the treated areas (cm)
Time Frame: 15 days after treatment
The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the horse's breeches.
15 days after treatment
Metric measurements of the treated areas (cm)
Time Frame: 3 months after treatment
The effectiveness of cryotherapy will be evaluated by the metric measurement of the treated areas: waist circumference, from the hips to the horse's breeches.
3 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
iDXA scanner measurement
Time Frame: 15 days
Measurement of subcutaneous fat mass in areas treated with the iDXA scanner
15 days
iDXA scanner measurement
Time Frame: 3 months
Measurement of subcutaneous fat mass in areas treated with the iDXA scanner
3 months
Metabolic assessment
Time Frame: 15 days after treatment
Metabolic assessment from a blood test: Liver function: Transaminase GOT, Transaminase GPT, Gamma GT (U/l)
15 days after treatment
Metabolic assessment
Time Frame: 15 days after treatment
Total cholesterol, triglycerides, HDL cholesterol (g/l)
15 days after treatment
Metabolic assessment
Time Frame: 15 days after treatment
Neopterin (nmol/l)
15 days after treatment
Metabolic assessment
Time Frame: 15 days after treatment
leptin (pg/l)
15 days after treatment
Metabolic assessment
Time Frame: 15 days after treatment
adipoleptin (mg/l)
15 days after treatment

Collaborators and Investigators

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

Sponsor

Clinic Cryo Esthetic

Investigators

  • Principal Investigator: Suva Loap, MD, Cryoesthetic

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 (Actual)

September 17, 2017

Primary Completion (Actual)

April 22, 2018

Study Completion (Actual)

September 17, 2018

Study Registration Dates

First Submitted

February 24, 2020

First Submitted That Met QC Criteria

February 25, 2020

First Posted (Actual)

February 27, 2020

Study Record Updates

Last Update Posted (Actual)

February 27, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-A01278-45

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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