Clinical trial NCT02129608: Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
Official title: A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overweight
Obese
Keywords: overweight
obese
central adiposity
Laser
lorcaserin
low level laser therapy
belviq
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2014-05-02
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: 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;

Primary outcomes:
measure: Change in Waist Circumference
timeFrame: 3 months
measure: Change in Weight
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ivana T. Croghan, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Croghan IT, Ebbert JO, Schroeder DR, Hurt RT, Hagstrom V, Clark MM. A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss. BMC Obes. 2016 Sep 29;3:42. doi: 10.1186/s40608-016-0122-4. eCollection 2016.