Clinical trial NCT04287153: Cryotherapy and Body Slimming
Official title: Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Cryotherapy Effect
Weight Loss
Keywords: obesity
cryotherapy
weight loss
saddlebags
Lead sponsor: Clinic Cryo Esthetic
Sponsor class: INDUSTRY
First posted: 2020-02-27
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Assessment of the effectiveness and tolerance of cryotherapy in the thinning of the abdomen and saddelbags
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Metric measurements of the treated areas (cm)
timeFrame: 15 days after treatment
measure: Metric measurements of the treated areas (cm)
timeFrame: 3 months after treatment
Secondary outcomes:
measure: iDXA scanner measurement
timeFrame: 15 days
measure: iDXA scanner measurement
timeFrame: 3 months
measure: Metabolic assessment
timeFrame: 15 days after treatment
measure: Metabolic assessment
timeFrame: 15 days after treatment
measure: Metabolic assessment
timeFrame: 15 days after treatment
measure: Metabolic assessment
timeFrame: 15 days after treatment
measure: Metabolic assessment
timeFrame: 15 days after treatment
Other outcomes:
Locations:
city: Paris
country: France
facility: Cryoesthetic
Study officials:
affiliation: Cryoesthetic
name: Suva Loap, MD
role: PRINCIPAL_INVESTIGATOR
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