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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLLT | Active Comparator | Low Level Laser Therapy (LLLT) once a week for 12 weeks |
|
| Lorcaserin | Active Comparator | locarserin monotherapy - 10 mg, twice daily for 12 weeks |
|
| LLLT and Lorcaserin | Active Comparator | LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLLT | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Waist Circumference | The change in waist circumference from baseline to 3 months | 3 months |
| Change in Weight | The change in weight from baseline to 3 months | 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ivana T. Croghan, PhD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27708788 | Result | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Lorcaserin | locarserin monotherapy - 10 mg, twice daily for 12 weeks Lorcaserin: 10 mg pills twice daily for 12 weeks. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Waist Circumference | The change in waist circumference from baseline to 3 months | Posted | Mean | Standard Deviation | cm | 3 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| dizziness | General disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ivana Croghan | Mayo Clinic | 507-266-1944 | domcro@mayo.edu |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D056128 | Obesity, Abdominal |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| D028022 | Low-Level Light Therapy |
| C506658 | lorcaserin |
| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| D013812 | Therapeutics |
| D010789 | Phototherapy |
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|
| Lorcaserin | Drug | 10 mg pills twice daily for 12 weeks. |
|
|
| Lorcaserin |
locarserin monotherapy - 10 mg, twice daily for 12 weeks Lorcaserin: 10 mg pills twice daily for 12 weeks. |
| BG002 | 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Weight (in kgs) | Mean | Standard Deviation | kg |
|
| waist circumference (in cm) | Mean | Standard Deviation | cm |
|
| 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. |
|
|
|
| Primary | Change in Weight | The change in weight from baseline to 3 months | Posted | Mean | Standard Deviation | kg | 3 months |
|
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Lorcaserin | locarserin monotherapy - 10 mg, twice daily for 12 weeks Lorcaserin: 10 mg pills twice daily for 12 weeks. | 0 | 14 | 2 | 14 |
| EG002 | 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. | 0 | 15 | 4 | 15 |
| nausea | Gastrointestinal disorders | Non-systematic Assessment |
|
| Headache | Nervous system disorders | Non-systematic Assessment |
|
| Low Blood Pressure | General disorders | Non-systematic Assessment |
|
| Tingling | General disorders | Non-systematic Assessment |
|
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| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| No |
| Superiority or Other |