Obesity Clinical Trial
— CryotherapyOfficial title:
Evaluation of the Effectiveness of Cryotherapy in Slimming of the Abdomen and Saddlebags
Verified date | February 2020 |
Source | Clinic Cryo Esthetic |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
France | Cryoesthetic | Paris |
Lead Sponsor | Collaborator |
---|---|
Clinic Cryo Esthetic |
France,
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
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 |
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