Sympathetic Activation in Obesity
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System
研究概览
简要总结
The primary objective of this study is to determine whether sympathetic nervous system (SNS) activity in white adipose tissue (WAT) and brown adipose tissue (BAT), skeletal muscle and brain is altered in individuals with obesity in comparison to individuals with normal weight. Simultaneous multi-organ SNS activation will be obtained with a radiotracer for norepinephrine transporter (NET) for whole-body Positron Emission Tomography (PET) imaging and microneurography (peroneal muscle SNS activity).
The secondary objectives of this study are: 1) to evaluate whether gender differences affect peripheral SNS in healthy normal weight and obese men and women in adipose tissue (WAT and BAT) and muscle (resting/fasting); 2) To investigate the relationship between peripheral and central SNS activity in obesity, by correlating SNS activity in peripheral tissues (WAT, BAT, and muscle) and brain; and 3) To investigate NET CNS and peripheral SNS activity before and after a high carbohydrate mixed meal in lean and obese men and women.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •In order to be eligible to participate in this study, an individual must meet all of the following criteria:
- •Provision of signed and dated informed consent form
- •Stated willingness to comply with all study procedures and availability for the duration of the study
- •Age 18-45 years
- •In good general health as evidenced by medical history and lean (BMI 18.5-24.9 kg/m2) or non-diabetic obese (BMI 30-50 kg/m2) with a fasting plasma glucose (FPG) <100 mg/dL and a hemoglobin A1c <5.7%.
排除标准
- •An individual who meets any of the following criteria will be excluded from participation in this study:
- •Hypertension
- •Cardiac or pulmonary disease,
- •Known history of Type 1 or Type 2 diabetes
- •Hepatic disease, swallowing and gastrointestinal disorders
- •Current use of anti-obesity medications, supplements and/or anti-hyperglycemic medications
- •Neurological injury or illness, and psychiatric medications
- •Women who are pregnant or lactating
- •Subjects who suffer from claustrophobia
- •Subjects who have received a diagnostic or therapeutic radiopharmaceutical within 7 days prior to participation in this study
- •Radiation works or participation in other research studies involving ionizing radiation within one year of the PET scans that would cause the subject to exceed the yearly dose limits.
- •Subjects with history of IV drug use which would prevent venous access for PET tracer injection
- •Severe motor problems that prevent the subject from lying still for PET and MR imaging
- •Subjects who complain of chronic pain
- •Blood donation within 8 weeks of the study
结局指标
主要结局
Distribution Volume Ratio (DVR) of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System
时间窗: 120 minutes
Lean individuals with a BMI of 18-25 and obese individuals with a BMI of 30-40 will undergo a PET/CT scan to determine group differences in sympathetic nervous system (SNS) activity in white adipose tissue (WAT), brown adipose tissue (BAT), and deltoid muscle. SNS activity will be determined by using \[11C\]MRB a radiotracer for PET imaging.
Microneurography (Muscle Sympathetic Nerve Activity (MSNA)) Measured by Burst Frequency
时间窗: 30-60 minutes
Muscle sympathetic nerve activity will be quantified by identification and measurement of sympathetic bursts in the integrated neurogram and expressed as burst frequency (mean number of bursts per unit time) to determinate group differences in peroneal MSNA at baseline (fasting) and during MMT.
次要结局
- DVR of Norepinephrine Transporter (NET) in the Central Nervous System (CNS)(120 minutes)
- Insulin Levels(2 hours)
- Plasma Free Fatty Acids (FFA)(2 hours)
- Plasma Glucose(2 hours)
- C-Peptide(2 hours)
- Thyroid Function Tests(2 hours)
- Electrocardiogram (EKG) - RR Interval(30-60 minutes)
- Plasma Catecholamines (Epinephrine and Norepinephrine)(2 hours)
- DVR of [11C]MRB PET Imaging of Peripheral Sympathetic Nervous System After Mixed Meal Test(120 minutes)
- Electrocardiogram (EKG)- Heart Rate(30-60 minutes)