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Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Central Reward System (BariBrainPET)

2021年10月12日 更新者：Pirjo Nuutila、Turku University Hospital

Effects of Morbid Obesity and Bariatric Surgery on Brain Inflammation, Insulin Resistance and Activation of Central Reward System Studied Using PET- and MRI-imaging

Background: Morbid obesity is associated with decreased brain µ-opioid receptor availability, possibly resulting in higher food intake needed to gain pleasure from eating. This decrease seems to normalize already 6 months after bariatric surgery, but the longer-term effects have not been studied. Obesity and insulin resistance result in significantly increased brain insulin-stimulated glucose uptake, whereas in every other tissue glucose uptake is lower. One possible explanation to this could be central inflammation and activation of brain glial cells, which has been shown to occur in animal models of obesity. Obesity has also been shown to associate with increased risk of Alzheimer's disease and cognitive decline in several studies.

Aims: The first objective of this study is to both study the effects of bariatric surgery as well as compare the effects of gastric bypass and sleeve gastrectomy on food-associated pleasure, extending the follow-up period to 2 years postoperatively. The second aim is to investigate the effect of morbid obesity and weight loss on brain inflammation and gliosis and its association with increased brain insulin-stimulated glucose uptake. Furthermore, association of obesity, insulin resistance, central inflammation and neurocognitive dysfunction are evaluated.

研究概览

地位

主动，不招人

条件

干预/治疗

详细说明

Methods: A total of 60 morbidly obese subjects, 30 assigned for Roux-en-Y gastric bypass and 30 for sleeve gastrectomy according to routine treatment protocols will be recruited for this study. A control group of 30 healthy subjects will also be recruited. We will perform 1) structural MRI and MRS, 2) functional MRI during tasting and visual food cues, 3) PET imaging of µ-opioid receptor availability using [11C]-carfentanil, 4) PET imaging of cerebral inflammation and astrocyte activation using [11C]-PK11195, 5) measurement of whole-body and tissue insulin sensitivity by combining hyperinsulinemic, euglycemic clamp with [18F]-FDG-PET, 6) neuropsychological testing. The control group will only be studied once, whereas study procedures will be repeated for the morbidly obese before very-low calorie diet and 6, 12 and 24 months postoperatively.

研究类型

介入性

注册 (实际的)

30

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

  • 芬兰
      • Turku、芬兰、20520
        • Turku PET Centre

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

18年 至 60年 (成人)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion criteria:

Morbidly obese group

  1. BMI 35.0-45.0 kg/m2, or BMI 32.0-45.0 kg/m2 and diagnosed diabetes
  2. Age 18-60 years
  3. Eligible to bariatric surgery evaluated according to normal treatment paradigm

Non-obese controls

  1. BMI 18-27 kg/m2
  2. Age 18-60 years
  3. Fasting plasma glucose ≤6.1 mmol/L
  4. Normal values in 2-hour oral glucose tolerance test

Exclusion criteria:

Morbidly obese group

  1. Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clipses, braces, foreign fragments)
  2. Previous participation in PET studies
  3. Pregnancy
  4. Poor compliance, alcohol or drug abuse
  5. Weight over 150 kg or waist circumference over 150 cm
  6. Diabetes with fasting glucose levels ≥7.0 mmol/L, or treatment with insulin
  7. Any chronic disease, medication or condition that could create a hazard to subject safety, endanger study procedures or interfere with the interpretation of results.

Non-obese controls

  1. Metal objects in the body (including pacemakers, metallic artificial valve prostheses, inner ear implants, surgical clipses, braces, foreign fragments)
  2. Previous participation in PET studies
  3. Pregnancy
  4. Poor compliance, alcohol or drug abuse
  5. Smoking
  6. History of eating disorders, drastic weight-gain or weight-loss
  7. History of psychiatric disorders
  8. Any chronic disease, medication or condition that could create a hazard to subject safety, endanger study procedures or interfere with the interpretation of results

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：治疗
  • 分配：非随机化
  • 介入模型：单组作业
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Morbidly obese subjects
Bariatric surgery (Roux-en-Y gastric bypass or sleeve gastrectomy)
程序：Bariatric surgery
Roux-en-Y gastric bypass or sleeve gastrectomy, chosen based on routine evaluation process
其他名称：
  • 袖状胃切除术
  • Roux-en-Y 胃旁路术
无干预：Control subjects
Non-obese controls are only studied at baseline

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Change in central inflammation
大体时间：Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Assessment of brain glial cell activation using [11C]-PK11195 tracer and positron emission tomography
Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively

次要结果测量

结果测量
措施说明
大体时间
Changes in central reward system using fMRI imaging
大体时间：Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Assessment of brain reward system activation after visual/taste cues using functional MRI
Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Changes in brain μ-opioid receptor availability using PET imaging
大体时间：Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months postoperatively
Assessment of brain μ-opioid receptor availability using [11C]-carfentanil tracer and positron emission tomography
Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months postoperatively
Changes in cognitive function studied with testing
大体时间：Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Neuropsychological testing focusing on memory, decision-making and inhibition
Controls: 0 months; Morbidly obese: preoperatively, 6 months, 12 months, 24 months postoperatively
Changes in whole-body insulin sensitivity usign FDG-PET imaging
大体时间：Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Assessment of whole-body insulin sensitivity using hyperinsulinemic, euglycemic clamp
Controls: 0 months; Morbidly obese: preoperatively, 6 months postoperatively
Changes in tissue-specific insulin sensitivity using FDG-PET imaging
大体时间：Controls: 0 months; Morbidly obese: preoperatively
Assessment of insulin-stimulated glucose uptake in the brain, liver, skeletal muscle and adipose tissue by performing positron emission tomography with [18F]-fluorodeoxyglucose tracer during hyperinsulinemic, euglycemic clamp
Controls: 0 months; Morbidly obese: preoperatively

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。

赞助

Turku University Hospital

调查人员

  • 首席研究员：Pirjo Nuutila, MD, PhD、Turku University Hospital

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 (实际的)

2019年2月11日

初级完成 (实际的)

2021年10月10日

研究完成 (预期的)

2022年12月1日

研究注册日期

首次提交

2018年6月6日

首先提交符合 QC 标准的

2021年10月12日

首次发布 (实际的)

2021年10月15日

研究记录更新

最后更新发布 (实际的)

2021年10月15日

上次提交的符合 QC 标准的更新

2021年10月12日

最后验证

2021年10月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • BariBrain-PET
  • T153/2018 (其他标识符：The Hospital District of Southwest Finland)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

Under preparation.

IPD 共享支持信息类型

  • 研究协议
  • 统计分析计划 (SAP)
  • 知情同意书 (ICF)
  • 临床研究报告（CSR）

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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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