Brown Adipose Tissue Activity in Response to Semaglutide Administered to Obese Subjects.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- change in supraclavicular temperature with cold exposure
研究概览
简要总结
Glucagon like peptide (GLP-1) agonists, such as liraglutide, exenatide, and semaglutide, have been increasingly used as a medication to address the current twin epidemics of diabetes and obesity. Their activities include increasing insulin production by pancreatic beta cells, improving insulin sensitivity in muscles and weight loss. The mechanisms underpinning the weight loss caused by GLP-1 agonists have not yet been fully elucidated, but brown adipose tissue (BAT) appears to play an important role.
We propose to assess BAT activity, using infrared thermography camera images, before individuals start weekly administration of semaglutide, at week 2-4, and week 18-20. We hypothesize that this GLP-1 agonist, semaglutide, will cause an increase in BAT activity and a corresponding increase in basal metabolic rate.
详细描述
Background and Rationale:
Glucagon like peptide (GLP-1) agonists, such as liraglutide, exenatide, and semaglutide, have been increasingly used as a medication to address the current twin epidemics of diabetes and obesity. Their activities include increasing insulin production by pancreatic beta cells, improving insulin sensitivity in muscles and weight loss. The mechanisms underpinning the weight loss caused by GLP-1 agonists have not yet been fully elucidated, but brown adipose tissue (BAT) appears to play an important role.
BAT is a type of adipose tissue which predominates in infants to allow thermoregulation through adaptive thermogenesis, but it is also present in adults. BAT activity also increases insulin sensitivity and whole body energy expenditure, and thus has the potential to treat type 2 diabetes and obesity. Bilateral supraclavicular and axillary BAT account for approximately two thirds of total body BAT content. Although the precise role of BAT in human metabolism and energy balance is unknown, a clear link exists between obesity and BAT dysfunction in humans.
It has been hypothesized that the prominent weight loss activity of GLP-1 agonists in humans is the result of BAT activation. However, studies with various GLP-1 agonists have been equivocal.
With more powerful GLP-1 agonists such as semaglutide entering in clinical practice, a better understanding of the relationship between GLP-1 and BAT is important. If BAT activity is found to be clinically significant as a mechanism of action of GLP-1 agonists, then the addition of adjuvants which enhance BAT activity could optimize the benefit of these medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects scheduled to start semaglutide for weight loss (drug not provided by or paid for by the study)
- •>18 years of age and willing to participate
- •Male or post-menopausal females
排除标准
- •History of prior neck surgery and /or neck irradiation
- •Use of beta blocker agents
- •Use of any other glucose lowering medication
- •History of neuropathic disorders (e.g. diabetic neuropathy)
- •Diabetic patients
- •Individuals without normal thyroid function
- •Individuals with cancer
- •Any significant chronic disease or renal, hepatic or endocrine disease
- •Current smokers
- •Inability of patient to provide consent either for medical reasons or psychiatric reasons
结局指标
主要结局
change in supraclavicular temperature with cold exposure
时间窗: 20weeks
delta temperature
basal metabolic rate
时间窗: 20 weeks
basal metabolic rate (ml O2/min or joule per hour per kg body mass)
change in caloric intake
时间窗: 20weeks
caloric intake
次要结局
未报告次要终点
研究者
Preethi Srikanthan, MD, MS
Professor
University of California, Los Angeles