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Cryotherapy and Body Slimming (Cryotherapy)

Primary Purpose

Obesity, Cryotherapy Effect, Weight Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cryotherapy on abdomen and saddlebags
Sponsored by
Clinic Cryo Esthetic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, cryotherapy, weight loss, saddlebags

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Cryoesthetic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Croytherapy on abdomen and saddlebags

Arm Description

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).

Outcomes

Primary Outcome Measures

Metric measurements of the treated areas (cm)
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.
Metric measurements of the treated areas (cm)
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

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

Full Information

First Posted
February 24, 2020
Last Updated
February 25, 2020
Sponsor
Clinic Cryo Esthetic
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1. Study Identification

Unique Protocol Identification Number
NCT04287153
Brief Title
Cryotherapy and Body Slimming
Acronym
Cryotherapy
Official Title
Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 17, 2017 (Actual)
Primary Completion Date
April 22, 2018 (Actual)
Study Completion Date
September 17, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clinic Cryo Esthetic

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Cryotherapy Effect, Weight Loss
Keywords
obesity, cryotherapy, weight loss, saddlebags

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Assessment of the effectiveness and tolerance of cryotherapy in the thinning of the abdomen and saddelbags
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Croytherapy on abdomen and saddlebags
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
Cryotherapy on abdomen and saddlebags
Intervention Description
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 Measure Information:
Title
Metric measurements of the treated areas (cm)
Description
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.
Time Frame
15 days after treatment
Title
Metric measurements of the treated areas (cm)
Description
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.
Time Frame
3 months after treatment
Secondary Outcome Measure Information:
Title
iDXA scanner measurement
Description
Measurement of subcutaneous fat mass in areas treated with the iDXA scanner
Time Frame
15 days
Title
iDXA scanner measurement
Description
Measurement of subcutaneous fat mass in areas treated with the iDXA scanner
Time Frame
3 months
Title
Metabolic assessment
Description
Metabolic assessment from a blood test: Liver function: Transaminase GOT, Transaminase GPT, Gamma GT (U/l)
Time Frame
15 days after treatment
Title
Metabolic assessment
Description
Total cholesterol, triglycerides, HDL cholesterol (g/l)
Time Frame
15 days after treatment
Title
Metabolic assessment
Description
Neopterin (nmol/l)
Time Frame
15 days after treatment
Title
Metabolic assessment
Description
leptin (pg/l)
Time Frame
15 days after treatment
Title
Metabolic assessment
Description
adipoleptin (mg/l)
Time Frame
15 days after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suva Loap, MD
Organizational Affiliation
Cryoesthetic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cryoesthetic
City
Paris
ZIP/Postal Code
75007
Country
France

12. IPD Sharing Statement

Citations:
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11603881
Citation
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PubMed Identifier
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Citation
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Citation
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Citation
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PubMed Identifier
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Citation
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Citation
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PubMed Identifier
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Citation
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Cryotherapy and Body Slimming

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