NCT02500004已完成不适用
Brown Adipose Tissue Activity and Energy Metabolism in Cachexia Induced by Cancer or Chronic Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Brown adipose tissue (BAT) activity measured by PET(-MRI)
研究概览
简要总结
To study BAT activity and energy metabolism in patients with cachexia induced by cancer or chronic disease.
详细描述
This is a prospective, cross-sectional study to determine BAT activity in cachectic patients with pancreatic or non-small cell lung cancer, and in cachectic patients with chronic obstructive pulmonary disease (COPD), and compare results with healthy individuals and non-cachectic COPD patients, matched for age and BMI.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Pancreatic cancer patients, or NSCLC cancer patients, or COPD patients
- •The diagnostic criterion for cachexia is unintentional weight loss more than 5% over the past 6 months or more than 2% in individuals with a body-mass index < 20 kg/m2 and muscle wasting assessed by DXA;
- •Age ≥ 30 years;
- •Gender: male and female;
- •Caucasians.
排除标准
- •Uncontrolled Diabetes Mellitus;
- •Patients with severe clotting disorder;
- •Patients with an active second malignancy;
- •Psychological unstable persons presumed unfit to perform the measurements, including claustrophobia;
- •Persons unable to lie or sit still for 1-2 hours;
- •Oxygen therapy;
- •Pregnant subjects;Subjects unable to undergo MRI (e.g. pacemaker; neurostimulator; implantable cardioverter-defibrillator (ICD) or leads; Foley bladder catheter; medication pump; cochlear or hearing implant; tattoos or other items that cannot be removed and include metal parts (for instance from operations in the past); metal splinter in the eye; vascular clips; denture, which contains magnets);
- •Subjects that received high doses of radiotherapeutic radiation of the neck and/or upper chest in their medical history;
- •Persons that received cervical or thoracic sympathectomy or have a nerve dysfunction which is likely to influence sympathetic nerves;
- •The use of medication that influences the sympathetic nerve system: ß-blockers, α-blockers, central anti-hypertensives, certain anti-depression drugs (MAO inhibitors, tricyclic anti-depressives), reserpine, cocaine, calciumblockers, labetalol, and certain tranquillizers (fenothiazines).
结局指标
主要结局
Brown adipose tissue (BAT) activity measured by PET(-MRI)
时间窗: participants will be followed for 2 weeks
The main endpoint of this study is BAT volume and intensity of activity in Standard Uptake Value (SUV) in the presence of cancer cachexia, COPD cachexia, and compared to non-cachectic COPD patients and healthy individuals, as assessed by 18F-fluoro-deoxyglucose (18F-FDG) PET-MRI scanning.
次要结局
- Resting metabolic rate measured by REE(participants will be followed for 2 weeks)
- Metabolic gene expression in WAT measured by biopsy of subcutaneous fat(participants will be followed for 2 weeks)
- Total energy metabolism measured by resting energy expenditure (REE) and doubly labeled water(participants will be followed for 2 weeks)
- Systemic inflammatory status measured in blood(participants will be followed for 2 weeks)
- Hormonal status measured in blood(participants will be followed for 2 weeks)
- Lean tissue mass measured by MRI, DXA, and doubly labeled water(participants will be followed for 2 weeks)
- Fat tissue mass measured by MRI, DXA, and doubly labeled water(participants will be followed for 2 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Muscle Wasting in Cancer (MWIC)CachexiaNCT03191955University of Edinburgh282
已完成
不适用
Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in HumansMetabolic SyndromeNCT01430338Korea University90
已完成
不适用
Brown adipose tissue activity and energy metabolism in cachexia induced by cancer or chronic disease'wasting syndrome' 'loss of lean body mass'100005461001799110029107NL-OMON43922Medisch Universitair Ziekenhuis Maastricht70
招募中
不适用
Brown Adipose Tissue Activity in Gilbert's SyndromeGilbert SyndromeNCT06336369Medical University of Vienna80
招募中
不适用
Metabolic and Immunological Phenotyping in Patients With CancerNon-Hematologic MalignancyCancerNCT04285242CCTU- Cancer Theme80