Overweight, Obese
Conditions
Keywords
overweight, obese, central adiposity, Laser, lorcaserin, low level laser therapy, belviq
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.
Interventions
DEVICELLLT
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.
DRUGLorcaserin
10 mg pills twice daily for 12 weeks.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Waist Circumference | 3 months | The change in waist circumference from baseline to 3 months |
| Change in Weight | 3 months | The change in weight from baseline to 3 months |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LLLT Low Level Laser Therapy (LLLT) once a week for 12 weeks
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. | 15 |
| Lorcaserin locarserin monotherapy - 10 mg, twice daily for 12 weeks
Lorcaserin: 10 mg pills twice daily for 12 weeks. | 14 |
| LLLT and Lorcaserin LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
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.
Lorcaserin: 10 mg pills twice daily for 12 weeks. | 15 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 0 | 2 |
Baseline characteristics
| Characteristic | LLLT and Lorcaserin | LLLT | Lorcaserin | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 15 Participants | 15 Participants | 14 Participants | 44 Participants |
| Age, Continuous | 45.4 years STANDARD_DEVIATION 13.3 | 45.4 years STANDARD_DEVIATION 9.9 | 40.6 years STANDARD_DEVIATION 11.5 | 43.9 years STANDARD_DEVIATION 11.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 15 Participants | 14 Participants | 14 Participants | 43 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 14 Participants | 44 Participants |
| Region of Enrollment United States | 15 participants | 15 participants | 14 participants | 44 participants |
| Sex: Female, Male Female | 13 Participants | 13 Participants | 11 Participants | 37 Participants |
| Sex: Female, Male Male | 2 Participants | 2 Participants | 3 Participants | 7 Participants |
| waist circumference (in cm) | 100.9 cm STANDARD_DEVIATION 10 | 105.3 cm STANDARD_DEVIATION 11.6 | 108.0 cm STANDARD_DEVIATION 15.7 | 104.7 cm STANDARD_DEVIATION 12.6 |
| Weight (in kgs) | 90.3 kg STANDARD_DEVIATION 14 | 96.0 kg STANDARD_DEVIATION 15.3 | 94.4 kg STANDARD_DEVIATION 16.2 | 93.5 kg STANDARD_DEVIATION 15 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 15 | 2 / 14 | 4 / 15 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 | 0 / 15 |
Outcome results
Primary
Change in Waist Circumference
The change in waist circumference from baseline to 3 months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LLLT | Change in Waist Circumference | -2.3 cm | Standard Deviation 4.1 |
| Lorcaserin | Change in Waist Circumference | -6.0 cm | Standard Deviation 7.3 |
| LLLT and Lorcaserin | Change in Waist Circumference | -4.0 cm | Standard Deviation 5.5 |
p-value: 0.398t-test, 2 sided
p-value: 0.436t-test, 2 sided
Primary
Change in Weight
The change in weight from baseline to 3 months
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| LLLT | Change in Weight | -1.0 kg | Standard Deviation 4.4 |
| Lorcaserin | Change in Weight | -3.7 kg | Standard Deviation 3.3 |
| LLLT and Lorcaserin | Change in Weight | -3.5 kg | Standard Deviation 3.6 |
p-value: 0.07t-test, 2 sided
p-value: 0.95t-test, 2 sided