- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02129608
Low Level Laser Treatment (LLLT) and Lorcaserin for Weight Management
September 30, 2016 updated by: Ivana Croghan, Mayo Clinic
A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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;
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: LLLT
Low Level Laser Therapy (LLLT) once a week for 12 weeks
|
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:
|
Active Comparator: Lorcaserin
locarserin monotherapy - 10 mg, twice daily for 12 weeks
|
10 mg pills twice daily for 12 weeks.
Other Names:
|
Active Comparator: LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
|
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:
10 mg pills twice daily for 12 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Waist Circumference
Time Frame: 3 months
|
The change in waist circumference from baseline to 3 months
|
3 months
|
Change in Weight
Time Frame: 3 months
|
The change in weight from baseline to 3 months
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ivana T. Croghan, PhD, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2014
Primary Completion (Actual)
December 1, 2015
Study Completion (Actual)
December 1, 2015
Study Registration Dates
First Submitted
April 25, 2014
First Submitted That Met QC Criteria
May 1, 2014
First Posted (Estimate)
May 2, 2014
Study Record Updates
Last Update Posted (Estimate)
November 22, 2016
Last Update Submitted That Met QC Criteria
September 30, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 14-002370
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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