Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management

NCT ID: NCT02129608

Last Updated: 2016-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-06-30
• Study Completion Date: 2015-12-31

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.

Conditions

Overweight; Obese

Keywords

overweight; obese; central adiposity; Laser; lorcaserin; low level laser therapy; belviq

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

LLLT

Low Level Laser Therapy (LLLT) once a week for 12 weeks

Group Type: ACTIVE_COMPARATOR

LLLT

Intervention Type: DEVICE

The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.

Lorcaserin

locarserin monotherapy - 10 mg, twice daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

Lorcaserin

Intervention Type: DRUG

10 mg pills twice daily for 12 weeks.

LLLT and Lorcaserin

LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks

Group Type: ACTIVE_COMPARATOR

LLLT

Intervention Type: DEVICE

The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.

Lorcaserin

Intervention Type: DRUG

10 mg pills twice daily for 12 weeks.

Interventions

LLLT

The LLLT uses 6 diode laser heads - each emitting 17 mW output. Subject will receive 30 minutes of therapy in the frontal central area and 30 minutes of therapy in the back central area, once a week for 12 weeks.

Intervention Type: DEVICE

Lorcaserin

10 mg pills twice daily for 12 weeks.

Intervention Type: DRUG

Other Intervention Names

Low Level Laser; Erchonia® Zerona™ 2.0 Laser; Belviq

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Ivana Croghan

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ivana T. Croghan, PhD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 27708788 (View on PubMed)

Related Links

http://bmcobes.biomedcentral.com/articles/10.1186/s40608-016-0122-4

Related Info

Other Identifiers

14-002370

Identifier Type: -

Identifier Source: org_study_id