NCT02798003终止不适用
Analysis of Food Reward System in Cachexia Induced by Acute or Chronic Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Reward-related activity in response to food cues, as indicated by Blood Oxygenation Level Dependent (BOLD) values in specified brain areas related to food reward.
研究概览
简要总结
To study activity in the reward-circuitry of the brain in patients suffering from cachexia induced by cancer or chronic disease.
详细描述
The activity in the food reward-circuitry of the brain in patients suffering from cachexia induced by cancer (lung cancer or pancreatic cancer) or chronic disease (chronic obstructive pulmonary disease) will be analysed by using functional magnetic resonance imaging. In addition, the role of the peripheral satiety hormones will be evaluated.
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
- 否
入选标准
- •For cachectic patients: weight loss exceeds 5% of total body weight over the past 6 months, or >2% when body mass index is <20 kg/m2
- •For non-cachectic patients: no weight loss of ≥5% during the last 6 months
- •Non-small cell lung cancer or gastro-intestinal cancer, pathology proven or diagnosis of COPD consistent with the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
排除标准
- •Contra-indications for fMRI examination (operation to your head or brain in the past; implanted electronic devices, for instance a pacemaker, neurostimulator, cochlear or hearing implant; insulin pump under your skin; Pregnant subjects, claustrophobia; pregnancy; metal parts in your body (except from teeth filling and connectors): implants; brain vessel clamps, prostheses, intra-uterine device, metal splinter in the eye, metal braces or other metal objects, permanent eye make-up)
- •Psychiatric or other disorders likely to impact on informed consent
- •Presence of brain metastasis (screening is not mandatory)
- •Medical history of cerebrovascular accident, brain tumour, brain metastasis
- •Previous radiotherapy to brain, both stereotactic and whole brain radiotherapy
- •Memory problems
- •Current use of tube feeding or parental nutrition
- •Patients with an active second malignancy
- •Patients unable to lie still for 2 hours
- •Unable to complete the cognitive task
- •Pre-existing swallowing difficulties
- •Allergy to gluten-, milk- or wheat products
- •Self-reported hyperthyroidism
- •Self-reported diabetes mellitus
- •Current use of appetite stimulant medications
结局指标
主要结局
Reward-related activity in response to food cues, as indicated by Blood Oxygenation Level Dependent (BOLD) values in specified brain areas related to food reward.
时间窗: 2 years
次要结局
- Blood parameters: leptin (ug/L)(2 years)
- Blood parameters: ghrelin (pg/mL)(2 years)
- Dietary intake assessed by a food diary(2 years)
- Blood parameters: glucose (mmol/L)(2 years)
- Blood parameters: insulin (pmol/L)(2 years)
- Blood parameters: glucagon-like peptide-1 (pmol/L)(2 years)
研究者
研究点 (1)
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