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Reduced Appetite in Crohn's Disease: The Role of the Brain in the Control of Food Intake

2019年4月16日 更新者:University of Nottingham

Reduced Appetite in Crohn's Disease: Investigating the Role of the Gut Brain Pathways

Crohn's disease (CD) is becoming more common, specifically in the western world. One of the main features of this disease is weight loss and malnutrition. Although clinically common, these problems are not well understood. Loss of appetite and symptoms such as tummy aches and bloating are common causes for weight loss in this group of patients. This problem has a strong negative effect on the patients' quality of life and significantly increases the cost of treating CD. Enteroendocrine cells are nutrient sensors in the bowel that relay to the brain to control food intake. Recent evidence has showed that these cells increase in number in active CD and secrete more hormones that negatively affect appetite. The increased levels of these hormones should have an overall negative effect on the brain and thus decrease food intake, bloating, symptoms of sickness. All these symptoms lead to malnutrition. These are hypotheses that require further proof. Current technological advances in magnetic resonance imaging (MRI) has enabled the mapping of changes in activity in important areas in the brain that control food intake. The involvement of the brain in control of food intake is still not fully understood. This work will be the first step in the right direction to start targeting the problems of appetite, weight loss and a poor quality of life.

研究概览

地位

完全的

条件

研究类型

介入性

注册 (实际的)

80

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Nottingham、英国、NG7 2RD
        • University of Nottingham
      • Nottingham、英国
        • University of Nottingham

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

16年 至 75年 (孩子、成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

Inclusion Criteria:

  1. Age 16-75 years
  2. Ulceration seen at ileocolonoscopy, aiming for a simple endoscopic score for Crohn's disease (SES-CD) of 4-19, in the absence of stricturing disease or,
  3. Intestinal inflammation or deep ulceration seen on CT or MR enterography, with the disease activity quantified via the MaRIA score or,
  4. Faecal calprotectin of >250µg/g
  5. C-Reactive protein >5mg/dl
  6. Harvey-Bradshaw index score of 5-16
  7. Body mass index (BMI) 18-35
  8. As for HV participants, inclusion criteria 1 and 7 will apply.

Exclusion Criteria:

  1. Malignant disease
  2. BMI <18 and >35
  3. Significant cardiovascular or respiratory disease
  4. Diabetes mellitus
  5. Current Infection
  6. Neurological or cognitive impairment; significant physical disability
  7. Significant hepatic disease or renal failure
  8. Abnormal blood results other than those explained by CD including bleeding diatheses (apart from in the case of HV where all unexplained blood results are an exclusion criteria)
  9. Subjects currently participating in (or in the last three months) any other research project
  10. pregnancy or breastfeeding or
  11. if MRI is contraindicated (e.g. pacemaker).
  12. Severe Crohn's disease where a delay in a change in medical treatment for 23 weeks would not be clinically advisable.
  13. As for healthy volunteer participants all exclusion criteria apart from no.12.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:基础科学
  • 分配:非随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:健康
健康志愿者
Test drink
实验性的:Crohn's Disease
Active Crohn's Disease
Test drink

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Changes in Blood Oxygenation Level Dependent (BOLD) response in the brain following a fatty acid test meal in Crohn's patients and healthy controls
大体时间:3 years
3 years

次要结果测量

结果测量
措施说明
大体时间
Changes in arterial spin labeling measures of cerebral blood flow and changes in gut peptide levels following the fatty acid test meal.
大体时间:3 years

The increase or decrease in BOLD signal of the brain following the fatty acid stimuli will be correlated to the gut peptide levels which are listed as follows:

  1. CCK (pmol/ml)
  2. GLP-1 (pM)
  3. PYY (pg/ml)
  4. Ghrelin (ng/ml)
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2015年6月1日

初级完成 (实际的)

2018年9月1日

研究完成 (实际的)

2018年9月1日

研究注册日期

首次提交

2016年2月11日

首先提交符合 QC 标准的

2016年5月10日

首次发布 (估计)

2016年5月13日

研究记录更新

最后更新发布 (实际的)

2019年4月17日

上次提交的符合 QC 标准的更新

2019年4月16日

最后验证

2017年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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