Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
Status:
Completed
Trial end date:
2015-12-01
Target enrollment:
Participant gender:
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.