Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
30 participants
INTERVENTIONAL
2017-09-17
2018-09-17
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Cold Therapy in the Treatment of Exercise-induced Muscle Damage
NCT02341612
Cold Induced Activation of Brown Adipose Tissue in Humans
NCT03096535
Acute Effects of Cryotherapy on Muscle Properties
NCT06608836
Cold Induced Activation of Brown Adipose Tissue in Winter Swimmers
NCT03095846
Cold Acclimation As a Modulator of Brown Adipose Tissue Function in Adults with Obesity
NCT05468151
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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)
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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)
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* 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
18 Years
45 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Clinic Cryo Esthetic
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Suva Loap, MD
Role: PRINCIPAL_INVESTIGATOR
Cryoesthetic
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Cryoesthetic
Paris, , France
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Aronne LJ. Epidemiology, morbidity, and treatment of overweight and obesity. J Clin Psychiatry. 2001;62 Suppl 23:13-22.
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.
Avram MM, Harry RS. Cryolipolysis for subcutaneous fat layer reduction. Lasers Surg Med. 2009 Dec;41(10):703-8. doi: 10.1002/lsm.20864.
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.
Bernstein EF. Longitudinal evaluation of cryolipolysis efficacy: two case studies. J Cosmet Dermatol. 2013 Jun;12(2):149-52. doi: 10.1111/jocd.12036.
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. doi: 10.1152/ajpregu.00021.2014.
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.
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.
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 2009 Jul 13.
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.
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.
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.
Saarelainen J, Hakulinen M, Rikkonen T, Kroger 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. 2016;2016:1424582. doi: 10.1155/2016/1424582. Epub 2016 Apr 27.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2017-A01278-45
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.