Cryotherapy and Body Slimming
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
Prospective, monocentric pilot and comparative (before and after) study in simple blind (assessor different from the operator).
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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.
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Measurement of subcutaneous fat mass with iDXA scanner on treated areas
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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 Design
Arms and Interventions
| 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)
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Outcome Measures
Primary Outcome Measures
- Metric measurements of the treated areas (cm) [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.
- 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
- iDXA scanner measurement [15 days]
Measurement of subcutaneous fat mass in areas treated with the iDXA scanner
- iDXA scanner measurement [3 months]
Measurement of subcutaneous fat mass in areas treated with the iDXA scanner
- Metabolic assessment [15 days after treatment]
Metabolic assessment from a blood test: Liver function: Transaminase GOT, Transaminase GPT, Gamma GT (U/l)
- Metabolic assessment [15 days after treatment]
Total cholesterol, triglycerides, HDL cholesterol (g/l)
- Metabolic assessment [15 days after treatment]
Neopterin (nmol/l)
- Metabolic assessment [15 days after treatment]
leptin (pg/l)
- Metabolic assessment [15 days after treatment]
adipoleptin (mg/l)
Eligibility Criteria
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:
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- < 18 years old.
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Pregnancy
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Breastfeeding
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Cold allergy: 2-minute ice cube test positive
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A waist/hip ratio indicative of a pathological fat distribution (>0.8 for women, >0.9 for men)
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Endocrine pathologies (Cushing's disease, endocrine tumours, unbalanced frank or labile hypothyroidism, hirsutism and hyper-androgenism, insulin resistance and/or unbalanced type 2 diabetes...)
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Neoplasia
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Psychiatric pathologies with or without treatment (Antidepressants, Neuroleptics, Anxiolytics...), well characterized anorexia-bulimia syndromes.
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Established alcoholism. Daily alcohol consumption should not exceed 2 glasses of wine per day.
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Digestive pathologies (especially hepatic) and functional digestive disorders (chronic constipation, alternating constipation-diarrhoea, chronic abdominal pain).
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Weaknesses of the abdominal wall (umbilical, inguinal, crural hernias)
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HIV in therapy
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Genetic deformities and diseases
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Vegetarian/vegetarian diet, macrobiotic diet
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Spasmophilia
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Surgery less than 3 months old
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Unbalanced coronary artery disease, untreated angina
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Cryoesthetic | Paris | France | 75007 |
Sponsors and Collaborators
- Clinic Cryo Esthetic
Investigators
- Principal Investigator: Suva Loap, MD, Cryoesthetic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2017-A01278-45