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fMRI and Appetite-Related Hormones Pre and Post Obesity Surgery

2014年1月10日 更新者:Dr. Allan Geliebter、New York Obesity and Nutrition Research Center

Functional Brain Imaging and Appetite-Related Hormones Pre and Post Obesity Surgery

The investigators are looking at the differences in appetite and obesity between weight loss participants and patients undergoing bariatric surgery.

Obese persons between the ages of 18 & 65 are eligible to participate in this study, whether or not they intend to undergo bariatric surgery.

研究概览

详细说明

Currently, the only effective long term treatment for severe obesity is bariatric surgery.2 Nearly 200,000 procedures are performed each year, with this number increasing rapidly.3 However, the mechanisms of reduced food intake and weight loss after obesity surgery, particularly Rouen-Y gastric bypass (RYGB), are not well understood. This study utilizes functional magnetic resonance imaging (fMRI) and measures of appetite-related gut peptide levels pre and post bariatric surgery to investigate the neurological and hormonal mechanisms involved in initiation and termination of meals.

The general objective is to better understand the physiological changes resulting in weight loss from obesity surgery, particularly Roux-en-Y gastric bypass (RYGB). The main hypothesis is that the differential mechanisms of action in RYGB will alter the signals involved in the initiation and termination of meals, reflected by changes in both peptide hormone levels and regional brain activity in response to foods. The investigators anticipate that the trigger for meal initiation by potent food stimuli will be diminished following RYGB, as indicated by reduced brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). RYGB will be compared to: a. Gastric Banding (GB), representing the restrictive component of surgery, which itself enhances fullness, but in the absence of any rerouting of the gut, should result in fewer changes in gut peptide levels and brain activation; b. Weight Loss (WL) on a formula diet over 3 mo, which represents the weight loss component of surgery; and c. No Treatment (NT), a general control, with no gastric restriction or weight loss. These group comparisons will help parse the contributions of RYGB surgery to weight loss.

The plan is to study clinically severe obese subjects (S's) pre surgery, and at 3 and 18 mo post surgery. The investigators will examine: 1) fMRI brain activation in response to food stimuli and 2) appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. The findings should reveal potential mechanisms associated with the changes in appetite, eating behaviors, and body weight, both during the rapid weight loss phase at 3 mo post surgery as well as when weight typically stabilizes at a nadir at 18 mo post surgery. The investigators plan to enroll 160 patients: 40 with RYGB, 40 GB, 40 WL, and 40 NT (4-arm study). S's will be within the BMI range of 40-50 and matched across groups for BMI, gender (3:1, f:m), and BED status.

研究类型

介入性

注册 (预期的)

160

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

    • New York
      • New York、New York、美国、10025
        • St. Luke's-Roosevelt Hospital Center

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 65年 (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:

  • BMI range 35-50 kg/m^2

Exclusion Criteria:

  • diabetes,
  • smoking,
  • pregnancy

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:并行分配
  • 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:Roux-en-Y Gastric Bypass
30 subjects who plan to undergo Roux-en-Y Gastric Bypass bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
其他名称:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
其他名称:
  • Food cue responses
实验性的:Gastric Banding (Lap-band)
30 subjects who plan to undergo Gastric Banding bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
其他名称:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
其他名称:
  • Food cue responses
实验性的:Formula Diet Weight Loss
30 subjects who plan to begin a formula diet to lose weight. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before subjects undertake a 12-week weight loss intervention (T1), at the end of the weight loss intervention (T2) and 18 months after they completed the weight loss intervention(T3).
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
其他名称:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
其他名称:
  • Food cue responses
实验性的:No Treatment
30 subjects who do not undergo any treatment for weight loss. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed at baseline (T1) and at 3 months (T2) and 18 months (T3) later.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
其他名称:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
其他名称:
  • Food cue responses
实验性的:Sleeve Gastrectomy Surgery
30 subjects who plan to undergo Sleeve Gastrectomy bariatric surgery. Liquid meal responses and Behavioral fMRI responses to food-cues will be assessed before surgery (T1), 3 months (T2) and 18 months (T3) after surgery.
Subject ingests a meal-replacement shake and gut peptide levels are measured before and after intake.
其他名称:
  • Meal replacement shake is the product Glytrol.
Subjects undergo a 40 min fMRI neuroimaging session while receiving auditory and visual food cues.
其他名称:
  • Food cue responses

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 brain activation in response to visual and auditory food cues
大体时间:3 mo pre-surgery and 3 and 18 mo post-surgery
Measures of brain brain activation in areas associated with food reward and motor planning, including the orbitofrontal cortex (OFC). Over the course of 40-min fMRI scans, we will compare change in activation from 3 mo pre-surgery to 3 and 18 mo post-surgery, and predict a post-surgical decrease in activation in such regions.
3 mo pre-surgery and 3 and 18 mo post-surgery

次要结果测量

结果测量
措施说明
大体时间
Anthropometrics and Body Composition
大体时间:3 mo pre-surgery and 3 and 18 mo post-surgery
Height and weight will be assessed using a stadiometer and digital scale. Sagittal diameter and waist and hip circumferences, as well as maximum supine width, will be measured. Waist circumference will be measured. Air displacement (Bioelectrical impedance analyses) will also be performed to obtain lean and fat mass. Weights, BMI, and body composition will confirm that the four obese groups are similar at baseline and provide estimates of changes in body fat following treatment.
3 mo pre-surgery and 3 and 18 mo post-surgery
Mood Measures
大体时间:3 mo pre-surgery and 3 and 18 mo post-surgery

We will administer relevant psychological instruments to assess Mood:

The Inventory of Depressive Symptomatology-Self Report (IDS-SR)will be assessed at 3mo pre-surgery, 3mo, 6mo and 18mo post surgery.

3 mo pre-surgery and 3 and 18 mo post-surgery
Change in appetite-related gut peptide levels
大体时间:3 mo pre-surgery and 3 and 18 mo post-surgery
We will measure changes in appetite-related gut peptide levels before and following a fixed meal prior to the fMRI. This will be assessed via blood plasma samples taken on 3 occasions: 3 mo pre-surgery, 3 mo post-surgery, and 18 mo post-surgery. At each session, there will be multiple time points: -15, 0, 15, 30, 60, and 90 minutes before/after ingestion of a meal replacement shake.
3 mo pre-surgery and 3 and 18 mo post-surgery
Eating Behavior
大体时间:3 mo pre-surgery and 3 and 18 mo post-surgery
We will administer relevant psychological instruments to assess Eating Behavior:including Eating Disorder Examination (EDE) to diagnose BED; Binge Eating Scale (BES), correlated with BED status; eating-related behavior (DEBQ - Restraint, Emotional, and Externality subscales); and dietary intake (24-Hour Food Recall).
3 mo pre-surgery and 3 and 18 mo post-surgery

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。

调查人员

  • 首席研究员:Allan Geliebter, PhD、New York Obesity Nutrition Research Center, St. Luke's-Roosevelt Hospital, Columbia University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

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

2010年7月1日

初级完成 (预期的)

2014年7月1日

研究完成 (预期的)

2015年7月1日

研究注册日期

首次提交

2012年3月9日

首先提交符合 QC 标准的

2012年4月23日

首次发布 (估计)

2012年4月24日

研究记录更新

最后更新发布 (估计)

2014年1月14日

上次提交的符合 QC 标准的更新

2014年1月10日

最后验证

2014年1月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 09-101

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.

Liquid meal responses的临床试验

3
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