A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.

Location:

Rochester, Minn.

Trial status:

Open for Enrollment

Why is this study being done?

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.

Who is eligible to participate?

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;

Last updated:

7/3/2014

NCT ID:

NCT02129608

IRB Number:

14-002370