Cryotherapy and Body Slimming

Not Applicable

Completed

• Conditions: Obesity; Cryotherapy Effect; Weight Loss
• Interventions: Device: Cryotherapy on abdomen and saddlebags

• Registration Number: NCT04287153
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-09-17
• Primary Completion: 2018-04-22
• Study Completion: 2018-09-17
• Status Verified: 2020-02
• Study First Submitted: 2020-02-24
• Study First Submitted QC: 2020-02-25
• Last Update Submitted: 2020-02-25
• Study First Posted: 2020-02-27
• Last Update Posted: 2020-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Croytherapy on abdomen and saddlebags	Cryotherapy 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).

Primary Outcome Measures

Name	Time	Method
Metric measurements of the treated areas (cm)	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

Name	Time	Method
Metabolic assessment	15 days after treatment	adipoleptin (mg/l)
iDXA scanner measurement	3 months	Measurement of subcutaneous fat mass in areas treated with the iDXA scanner

Trial Locations

Locations (1)

Cryoesthetic; 🇫🇷 Paris, France