Cryotherapy and Body Slimming

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Obesity, Cryotherapy Effect, Weight Loss

Intervention / Treatment
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* Device: Cryotherapy on abdomen and saddlebags


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Assessment of the effectiveness and tolerance of cryotherapy in the thinning of the abdomen and saddelbags
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Croytherapy on abdomen and saddlebags<br>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<br>* Application of variable temperature (-10°c to -7°c) on the treated areas using the cryotherapy device FG660L-006 (Beijing ADSS Development CO., Ltd)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 15 days after treatment | 
| 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. | 3 months after treatment | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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obesity, cryotherapy, weight loss, saddlebags