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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Mayo Clinic
Sponsor:
Information provided by (Responsible Party):
Ivana Croghan, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT02129608
First received: April 25, 2014
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Overweight
Obese
Device: LLLT
Drug: Lorcaserin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Reduction in central adiposity [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The reduction in the waist-hip ratio, body mass index and weight will be use to assess reduction in central adiposity.


Estimated Enrollment: 45
Study Start Date: June 2014
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LLLT
Low Level Laser Therapy (LLLT) once a week for 12 weeks
Device: 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.
Other Names:
  • Low Level Laser
  • Erchonia® Zerona™ 2.0 Laser
Active Comparator: Lorcaserin
locarserin monotherapy - 10 mg, twice daily for 12 weeks
Drug: Lorcaserin
10 mg pills twice daily for 12 weeks.
Other Name: Belviq
Active Comparator: LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
Device: 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.
Other Names:
  • Low Level Laser
  • Erchonia® Zerona™ 2.0 Laser
Drug: Lorcaserin
10 mg pills twice daily for 12 weeks.
Other Name: Belviq

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

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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;
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02129608

Contacts
Contact: Donna Rasmussen, RN 507-266-1944 domcro@mayo.edu
Contact: Richard Morris, BA 507-266-1944 domcro@mayo.edu

Locations
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Donna Rasmussen, RN    507-266-1944    domcro@mayo.edu   
Contact: Richard Morris, BA    507-266-1944    domcro@mayo.edu   
Sub-Investigator: Jon Ebbert, MD         
Principal Investigator: Ivana Croghan, PhD         
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Ivana T. Croghan, PhD Mayo Clinic
  More Information

No publications provided

Responsible Party: Ivana Croghan, PhD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT02129608     History of Changes
Other Study ID Numbers: 14-002370
Study First Received: April 25, 2014
Last Updated: July 3, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
overweight
obese
central adiposity
Laser
lorcaserin
low level laser therapy
belviq

Additional relevant MeSH terms:
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014