Nicotinic Agonist Effects on BMI and Neuronal Response in Overweight/Obese Adults
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Neuronal Response to Visual Food Cues
研究概览
简要总结
Obesity is a serious and growing health problem in the United States. Obesity is associated with health problems such as type-2 diabetes and cardiovascular disease, leading to decreased quality of life and increased mortality. Given the health and quality-of-life effects of obesity, developing effective treatments clearly is an important goal.
This study plans to learn more about the effects of an investigational new drug (DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine)) and its effects on obesity. The study drug has similar effects to nicotine. Since nicotine has been found to affect appetite, the investigators are interested in studying effects of the study drug, which has some similarities to nicotine, on how your brain responds to such things as pictures of food. The study drug has not been approved by the Food and Drug Administration (FDA), and is considered experimental.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overweight/obese (BMI > 27)
- •Between 21-65 years old
排除标准
- •Known cardiovascular disease (e.g., coronary artery disease, uncontrolled hypertension
- •Women capable of conception (must be post-menopausal, surgically sterilized, or have adhered to an anti-contraception birth control regimen for at least 1 year)
- •Nicotine use
- •Significant endocrine/metabolic disease
- •Kidney disease
- •Neurological illness
- •Liver disease
- •Medication use affecting appetite and/or metabolism
- •MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)
研究组 & 干预措施
DMXB-A
150 mg DMXB-A (3-(2,4-dimethoxybenzylidene anabaseine) b.i.d. for 12 weeks.
干预措施: DMXB-A (Drug)
Placebo
Placebo capsules b.i.d. for 12 weeks.
干预措施: Placebo (Other)
结局指标
主要结局
Neuronal Response to Visual Food Cues
时间窗: 14 weeks
Neuronal response (insula) while viewing visual food cues
Resting-state Neuronal Response
时间窗: 14 weeks
Neuronal response (default mode network) during rest
次要结局
- Body Weight(14 weeks)
- Fat Mass(14 weeks)
- Appetite Rating(14 weeks)