Metabolic Disease — Study of White Adipose Tissue Remodeling by Cryolipolysis in Humans
Citation(s)
Agrawal M, Kern PA, Nikolajczyk BS The Immune System in Obesity: Developing Paradigms Amidst Inconvenient Truths. Curr Diab Rep. 2017 Aug 15;17(10):87. doi: 10.1007/s11892-017-0917-9. Review.
Harms M, Seale P Brown and beige fat: development, function and therapeutic potential. Nat Med. 2013 Oct;19(10):1252-63. doi: 10.1038/nm.3361. Epub 2013 Sep 29. Review.
Ingargiola MJ, Motakef S, Chung MT, Vasconez HC, Sasaki GH Cryolipolysis for fat reduction and body contouring: safety and efficacy of current treatment paradigms. Plast Reconstr Surg. 2015 Jun;135(6):1581-1590. doi: 10.1097/PRS.0000000000001236. Review.
Kajimura S, Spiegelman BM, Seale P Brown and Beige Fat: Physiological Roles beyond Heat Generation. Cell Metab. 2015 Oct 6;22(4):546-59. doi: 10.1016/j.cmet.2015.09.007. Review.
Kilmer SL, Burns AJ, Zelickson BD Safety and efficacy of cryolipolysis for non-invasive reduction of submental fat. Lasers Surg Med. 2016 Jan;48(1):3-13. doi: 10.1002/lsm.22440. Epub 2015 Nov 26.
Kilmer SL Prototype CoolCup cryolipolysis applicator with over 40% reduced treatment time demonstrates equivalent safety and efficacy with greater patient preference. Lasers Surg Med. 2017 Jan;49(1):63-68. doi: 10.1002/lsm.22550. Epub 2016 Jun 21.
Krueger N, Mai SV, Luebberding S, Sadick NS Cryolipolysis for noninvasive body contouring: clinical efficacy and patient satisfaction. Clin Cosmet Investig Dermatol. 2014 Jun 26;7:201-5. doi: 10.2147/CCID.S44371. eCollection 2014. Review.
Nelson AA, Wasserman D, Avram MM Cryolipolysis for reduction of excess adipose tissue. Semin Cutan Med Surg. 2009 Dec;28(4):244-9. doi: 10.1016/j.sder.2009.11.004.
Shek SY, Chan NP, Chan HH Non-invasive cryolipolysis for body contouring in Chinese--a first commercial experience. Lasers Surg Med. 2012 Feb;44(2):125-30. doi: 10.1002/lsm.21145. Erratum in: Lasers Surg Med. 2012 Jul;44(5):435.
Stevens WG, Bachelor EP Cryolipolysis conformable-surface applicator for nonsurgical fat reduction in lateral thighs. Aesthet Surg J. 2015 Jan;35(1):66-71. doi: 10.1093/asj/sju024.
Sun K, Kusminski CM, Scherer PE Adipose tissue remodeling and obesity. J Clin Invest. 2011 Jun;121(6):2094-101. doi: 10.1172/JCI45887. Epub 2011 Jun 1. Review.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.