We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryotherapy and Body Slimming (Cryotherapy)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04287153
Recruitment Status : Completed
First Posted : February 27, 2020
Last Update Posted : February 27, 2020
Sponsor:
Information provided by (Responsible Party):
Clinic Cryo Esthetic

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Obesity Cryotherapy Effect Weight Loss Device: Cryotherapy on abdomen and saddlebags Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description: Assessment of the effectiveness and tolerance of cryotherapy in the thinning of the abdomen and saddelbags
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags
Actual Study Start Date : September 17, 2017
Actual Primary Completion Date : April 22, 2018
Actual Study Completion Date : September 17, 2018

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)




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. iDXA scanner measurement [ Time Frame: 15 days ]
    Measurement of subcutaneous fat mass in areas treated with the iDXA scanner

  2. iDXA scanner measurement [ Time Frame: 3 months ]
    Measurement of subcutaneous fat mass in areas treated with the iDXA scanner

  3. Metabolic assessment [ Time Frame: 15 days after treatment ]
    Metabolic assessment from a blood test: Liver function: Transaminase GOT, Transaminase GPT, Gamma GT (U/l)

  4. Metabolic assessment [ Time Frame: 15 days after treatment ]
    Total cholesterol, triglycerides, HDL cholesterol (g/l)

  5. Metabolic assessment [ Time Frame: 15 days after treatment ]
    Neopterin (nmol/l)

  6. Metabolic assessment [ Time Frame: 15 days after treatment ]
    leptin (pg/l)

  7. Metabolic assessment [ Time Frame: 15 days after treatment ]
    adipoleptin (mg/l)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04287153


Locations
Layout table for location information
France
Cryoesthetic
Paris, France, 75007
Sponsors and Collaborators
Clinic Cryo Esthetic
Investigators
Layout table for investigator information
Principal Investigator: Suva Loap, MD Cryoesthetic
Publications of Results:

Layout table for additonal information
Responsible Party: Clinic Cryo Esthetic
ClinicalTrials.gov Identifier: NCT04287153    
Other Study ID Numbers: 2017-A01278-45
First Posted: February 27, 2020    Key Record Dates
Last Update Posted: February 27, 2020
Last Verified: February 2020

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Clinic Cryo Esthetic:
obesity
cryotherapy
weight loss
saddlebags
Additional relevant MeSH terms:
Layout table for MeSH terms
Weight Loss
Body Weight
Body Weight Changes