A Feasibility Pilot Comparing a Non-invasive Low Level Laser Therapy (LLLT) With Lorcaserin to Reduce Central Adiposity in Overweight Individuals.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change in Waist Circumference
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
LLLT
Low Level Laser Therapy (LLLT) once a week for 12 weeks
干预措施: LLLT (Device)
Lorcaserin
locarserin monotherapy - 10 mg, twice daily for 12 weeks
干预措施: Lorcaserin (Drug)
LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
干预措施: LLLT (Device)
LLLT and Lorcaserin
LLLT once a week for 12 weeks and 10 mg of Lorcaserin twice daily for 12 weeks
干预措施: Lorcaserin (Drug)
结局指标
主要结局
Change in Waist Circumference
时间窗: 3 months
The change in waist circumference from baseline to 3 months
Change in Weight
时间窗: 3 months
The change in weight from baseline to 3 months
次要结局
未报告次要终点