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The purpose of this protocol is to investigate, using functional magnetic resonance imaging (fMRI), the effect of treatment with lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's downstream metabolic effects.
The purpose of this protocol is to investigate the effect of treatment with the study drug, called lorcaserin on centers of the brain that control appetite and food intake, as well as lorcaserin's other metabolic effects. Lorcaserin's effect on the brain will be investigated using functional magnetic resonance imaging (fMRI). Lorcaserin was approved in June 2012 as an addition to a reduced-calorie diet and exercise, for chronic weight management. Previous weight loss drugs, such as fenfluramine, acted throughout the body and caused heart problems. Lorcaserin is different because it only acts on receptors (sites of action) that are found in the brain and does not act on the heart, and thus, has not been shown to cause the heart problems seen in the past.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Subjects will be randomized to either placebo or Lorcaserin HCl. |
|
| Active | Active Comparator | Subjects will be randomized to either placebo or Lorcaserin HCl. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lorcaserin HCl | Drug | Lorcaserin is a weight-loss drug developed by Arena Pharmaceuticals. It has serotonergic properties and acts as an anorectic. |
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| Measure | Description | Time Frame |
|---|---|---|
| fMRI (Functional changes in the brain) | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition (DEXA) | Changes in body composition will be assessed by the following measurements: DEXA (Dual Energy X-Ray Absorptiometry): Body composition and bone density will be measured by DEXA. For the DEXA test, the subject will be lying on an examination bed for about 25 minutes. A small part of the DEXA machine will be recording and moving back and forth about 3 feet above their body. The radiation the subject will get is very small and is much less than what one gets from a regular chest X-Ray. Anthropometry: Anthropometry will be performed by a licensed dietician. Measurements include: Height, Weight, umbilical and smallest waist, broadest and iliac hip measurements. |
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Inclusion Criteria:
Obese: BMI> 30 kg/m2 or >27 kg/m2 with comorbidities (including but not limited to insulin resistance, hypertension, dyslipidemia, cardiovascular disease, stroke, sleep apnea, gallbladder disease, hyperuricemia and gout, and osteoarthritis).
Additionally, women participants must use double barrier methods to prevent pregnancy (diaphragm with intravaginal spermicide, cervical cap, male or female condom with spermicide). If a woman suspects that she has become pregnant at any time or does not use one of the contraceptive methods recommended by the investigator, she must notify the study staff. If a woman becomes pregnant, she will be withdrawn from the study. The study staff will follow the progress of her pregnancy and the birth of her child.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christos S Mantzoros, MD DSc | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27385157 | Derived | Farr OM, Upadhyay J, Gavrieli A, Camp M, Spyrou N, Kaye H, Mathew H, Vamvini M, Koniaris A, Kilim H, Srnka A, Migdal A, Mantzoros CS. Lorcaserin Administration Decreases Activation of Brain Centers in Response to Food Cues and These Emotion- and Salience-Related Changes Correlate With Weight Loss Effects: A 4-Week-Long Randomized, Placebo-Controlled, Double-Blind Clinical Trial. Diabetes. 2016 Oct;65(10):2943-53. doi: 10.2337/db16-0635. Epub 2016 Jul 6. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C506658 | lorcaserin |
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| Placebo | Drug | This is a placebo oral pill that is a visual replica of the Lorcaserin medication but with no active ingredients. |
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| 6 months |
| Metabolic Rate (Resting Metabolic Rate (RMR) | Resting Metabolic Rate (RMR): RMR is the amount of calories the subject burn without doing any physical work. The subject's RMR will be measured with a commonly used instrument. The subject will be asked to lie quietly in bed and stay awake with a large plastic hood over the subject's head and upper body for about 20 minutes. The subject will breathe normally while the air they breathe out is collected and analyzed. | 6 months |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |