low level laser treatment (lllt) and lorcaserin for weight management

Conditions: Overweight; Obese

Summary: currently in the united states about 97 million adults are considered obese, accounting for about 33% of the american adult population (compared to 22.9% in 1988). obesity, defined as a body mass index of 30.0 or higher, is accountable for 44% of the diabetes, 23% of the ischemic heart disease and between 7% and 41% of certain cancers. the erchonia® zerona™ 2.0 laser (which will be used in this study) has been approved by the fda (k123237) as a non-invasive dermatological aesthetic treatment which can be used by individuals intending to reduce circumference of hips, waist, and thighs. lorcaserin is a selective serotonin 2c (5-ht(2c)) receptor agonist. the exact mechanism of action is not known, but lorcaserin is believed to promote satiety and decrease food intake by activating 5-ht(2c) receptors on anorexigenic pro-opiomelanocortin neurons in the hypothalamus. lorcaserin was approved by the fda on june 2012 for weight management in people with a bmi of \> 27 kg/m2 (overweight) when accompanied by a weigh-related condition such as type 2 diabetes or high blood pressure or in people with a bmi \> 30 kg/m2 (obese). the purpose of this pilot study is to obtain preliminary data on: 1) effectiveness of the combination of lllt and lorcaserin for reducing abdominal subcutaneous fat in overweight/obese individuals; 2) impact of lllt on inflammatory biomarkers, blood sugar, and cholesterol.

this study is being done to find out how effective low level laser therapy (lllt - erchonia® zerona™ 2.0 laser) is compared to lorcaserin (belviq®) in helping overweight people reduce their weight gain - especially in the central body region. subjects will undergo 2 screening visits in which the investigators will take their medical and weight concern histories; and if found eligible, they will be randomized to one of three groups: 1) 12 weeks of lllt, 2) 12 weeks of lorcaserin, and 3) 12 weeks of a combination of both lorcaserin and lllt. full study participation will last approximately 6 months and consists of 10 visits- 9 clinical and 1 phone call. during this study subjects will be provided with weight prevention counseling and be asked to complete 3 additional fasting blood draws. there will be one urine pregnancy test (for females only) at the beginning of the study.

Eligibility criteria:
inclusion criteria: * be 18-70 years of age; * have a body weight of greater than 50 kg (110 pounds); * have a bmi 27-39.9 kg/m2; * be weight concerned; * be motivated to reduce their central adiposity; * be able to participate fully in all aspects of the study; * have understood and signed study informed consent. exclusion criteria: * have used weight loss medications or participated in a weight loss program within the past 30 days; * are currently taking supplements known to affect weight, such as garcinia cambrogia. * have had weight fluctuations of 20 pounds or more in the past 6 months (self-report); * have an implanted device (including pacemaker or lap band) in the targeted area of lllt; * have an active untreated clinically significant psychiatric condition (psychosis, bipolar disorder, or depression); * have used an investigational drug within 30 days of study enrollment; * have a recent history (past 30 days) of alcohol or drug abuse or dependence; * are currently pregnant or lactating, or are of child-bearing potential or are likely to become pregnant during the medication phase and are unwilling to use a reliable form of contraception; * have a history of any major cardiovascular events including heart valve disease, cardiac arrhythmias, congestive heart failure, acute coronary syndrome, stroke, transient ischemic attack, or peripheral vascular disease; * have current uncontrolled hypertension (systolic \> 165 mm hg or diastolic \> 95 mm hg) documented on 2 separate occasions; * have clinically significant acute or chronic progressive or unstable neurologic, hepatic, renal, cardiovascular, lymphatic, respiratory, or metabolic disease (such as diabetes) or active cancer or are within 1 year of cancer remission; * prior surgical intervention for body sculpting/weight loss, such as liposuction, abdominoplasty, stomach stapling, lap band surgery, etc.; * medical, physical, or other contraindications for body sculpting/weight loss; * current use of medication(s) known to affect weight levels/cause bloating or swelling and for which abstinence during the course of study participation is not safe or medically prudent; * concurrently taking a serotonergic drug (selective serotonin reuptake inhibitors (ssris), serotonin-norepinephrine reuptake inhibitors (snris), monoamine oxidase inhibitors (maois), triptans, bupropion, dextromethorphan, st. john's wort). these drugs can be used to treat depression and/or migraines but are contraindicated with lorcaserin; * any medical condition known to affect weight levels and/or to cause bloating or swelling; * diagnosis of, and/or taking medication for, irritable bowel syndrome; * active infection, wound or other external trauma to the areas to be treated with the laser; * known photosensitivity disorder; * are allergic to lorcaserin; * current active cancer or currently receiving treatment for cancer; or * have a known history of any condition or factor judged by the investigator to preclude participation in the study or which might hinder adherence;

Keywords: overweight obese central adiposity laser lorcaserin low level laser therapy belviq