Cryotherapy and Body Slimming

Obesity Clinical Trial

— Cryotherapy  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04287153
• Other study ID #: 2017-A01278-45
• Status: Completed
• Phase: N/A
• Start date: September 17, 2017
• Est. completion date: September 17, 2018

Study information

• Verified date: February 2020
• Source: Clinic Cryo Esthetic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 17, 2018
• Est. primary completion date: April 22, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Cryotherapy Effect
• Obesity
• Weight Loss

Intervention

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)

Locations

Country	Name	City	State
France	Cryoesthetic	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Clinic Cryo Esthetic

Country where clinical trial is conducted

France, 

References & Publications (13)

Aronne LJ. Epidemiology, morbidity, and treatment of overweight and obesity. J Clin Psychiatry. 2001;62 Suppl 23:13-22. Review. — View Citation

Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864. Review. Erratum in: Lasers Surg Med. 2012 Jul;44(5):436. — View Citation

Bernstein EF. Longitudinal evaluation of cryolipolysis efficacy: two case studies. J Cosmet Dermatol. 2013 Jun;12(2):149-52. doi: 10.1111/jocd.12036. — View Citation

Coleman SR, Sachdeva K, Egbert BM, Preciado J, Allison J. Clinical efficacy of noninvasive cryolipolysis and its effects on peripheral nerves. Aesthetic Plast Surg. 2009 Jul;33(4):482-8. doi: 10.1007/s00266-008-9286-8. Epub 2009 Mar 19. — View Citation

Dierickx CC, Mazer JM, Sand M, Koenig S, Arigon V. Safety, tolerance, and patient satisfaction with noninvasive cryolipolysis. Dermatol Surg. 2013 Aug;39(8):1209-16. doi: 10.1111/dsu.12238. Epub 2013 May 2. — View Citation

Garibyan L, Sipprell WH 3rd, Jalian HR, Sakamoto FH, Avram M, Anderson RR. Three-dimensional volumetric quantification of fat loss following cryolipolysis. Lasers Surg Med. 2014 Feb;46(2):75-80. doi: 10.1002/lsm.22207. Epub 2013 Dec 3. — View Citation

Kennedy J, Verne S, Griffith R, Falto-Aizpurua L, Nouri K. Non-invasive subcutaneous fat reduction: a review. J Eur Acad Dermatol Venereol. 2015 Sep;29(9):1679-88. doi: 10.1111/jdv.12994. Epub 2015 Feb 9. Review. — View Citation

Lee P, Swarbrick MM, Ho KK. Brown adipose tissue in adult humans: a metabolic renaissance. Endocr Rev. 2013 Jun;34(3):413-38. doi: 10.1210/er.2012-1081. Epub 2013 Apr 2. Review. — View Citation

Manstein D, Laubach H, Watanabe K, Farinelli W, Zurakowski D, Anderson RR. Selective cryolysis: a novel method of non-invasive fat removal. Lasers Surg Med. 2008 Nov;40(9):595-604. doi: 10.1002/lsm.20719. — View Citation

Mulholland RS, Paul MD, Chalfoun C. Noninvasive body contouring with radiofrequency, ultrasound, cryolipolysis, and low-level laser therapy. Clin Plast Surg. 2011 Jul;38(3):503-20, vii-iii. doi: 10.1016/j.cps.2011.05.002. Review. — View Citation

Saarelainen J, Hakulinen M, Rikkonen T, Kröger H, Tuppurainen M, Koivumaa-Honkanen H, Honkanen R, Hujo M, Jurvelin JS. Cross-Calibration of GE Healthcare Lunar Prodigy and iDXA Dual-Energy X-Ray Densitometers for Bone Mineral Measurements. J Osteoporos. 2 — View Citation

van der Lans AA, Wierts R, Vosselman MJ, Schrauwen P, Brans B, van Marken Lichtenbelt WD. Cold-activated brown adipose tissue in human adults: methodological issues. Am J Physiol Regul Integr Comp Physiol. 2014 Jul 15;307(2):R103-13. Review. — View Citation

Zelickson B, Egbert BM, Preciado J, Allison J, Springer K, Rhoades RW, Manstein D. Cryolipolysis for noninvasive fat cell destruction: initial results from a pig model. Dermatol Surg. 2009 Oct;35(10):1462-70. doi: 10.1111/j.1524-4725.2009.01259.x. Epub 20 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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