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Neurobiology of Anorexia and Bulimia Nervosa

Primary Purpose

Anorexia Nervosa, Bulimia Nervosa

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Imaging
fast
regulated meals
Sponsored by
University of California, San Diego
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Anorexia Nervosa

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Must have had a DSM-IV diagnosis of anorexia or bulimia nervosa
  • The onset of their illness must have been at least 4 years prior to participating in this study
  • Must have recovered for 12 months or more prior to entering the study.

Exclusion Criteria:

  • Met diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study.
  • Current diagnosis of a severe major affective or anxiety disorder or presence of other psychopathology that might interfere with ability to participate in the study.
  • Organic brain syndromes, dementia, psychotic disorders or mental retardation
  • Neurological or medical disorders
  • Use of psychoactive medication in the 3 months prior to the study.
  • Pregnancy or lactation, lack of effective birth control during 15 days before the scans.

Sites / Locations

  • UCSD General Clinical Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1

2

Arm Description

Period of 12 hours where participants eat regulated meals

Period of 12 hours where participants do not eat anything

Outcomes

Primary Outcome Measures

Anterior insula (AI) and orbital frontal cortex (OFC) response to sucrose(relative to ionic water)
fMRI BOLD response

Secondary Outcome Measures

Full Information

First Posted
February 23, 2009
Last Updated
November 10, 2020
Sponsor
University of California, San Diego
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1. Study Identification

Unique Protocol Identification Number
NCT04626219
Brief Title
Neurobiology of Anorexia and Bulimia Nervosa
Official Title
Neurobiology of Anorexia and Bulimia Nervosa
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
February 2009 (Actual)
Primary Completion Date
March 2014 (Actual)
Study Completion Date
March 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to investigate areas of the brain responsible for appetite regulation. More specifically, the investigators would like to study changes in brain activation, e.g., changes in blood flow and oxygen use of the brain, during two different states: Once when the participants are hungry, and once when the participants are not hungry. The aim is to find out more about the neurobiology of Anorexia and Bulimia Nervosa by comparing women who never had an eating disorder with women who have recovered from Anorexia or Bulimia Nervosa.
Detailed Description
The main goal of this study is to explore the effects of hunger and satiety on regions in our brain in order to better understand the pathophysiology underlying restricted eating in anorexics, and overeating in women with Bulimia Nervosa. The investigators will adopt a paradigm that will model, in the laboratory, the naturalistic extremes of dietary intake practiced by women recovered from Anorexia or Bulimia Nervosa by comparing a hungry state (21-hour fast) to a satiated state (21-hour when fed). They may share an inability to precisely modulate emotionality and reward in response to salient stimuli, such as food. However, they may differ in terms of function of other pathways. The incentive motivational drive to seek and consume food is a complex process, deriving from interrelated psychobiological factors including food's rewarding properties, an individual's homeostatic needs and cognitive ability to favor alternative behaviors. In order to examine how these factors may contribute to dysregulated feeding behavior in women recovered from Anorexia or Bulimia Nervosa, the investigators will explore measures of 1) anxiety; 2) cognitive inhibition and dysinhibition; and 3) reward. Subjects will also be asked to undergo a Magnetic Resonance Imaging (MRI) scan of their head. This scan uses powerful magnetic fields. The magnetic fields temporarily magnetize some of the chemicals in our brain and this allows a scanner and a computer to take a very detailed picture of the structure of our brain. During the MRI, the participants will be asked to lie quietly inside the center of a large, doughnut shaped magnet for approximately 30 minutes. The participant's head will be placed in a special, helmet-like "head-holder" to help them to keep their head still. This part of the study will take place on the same day prior to the first PET scan. In this protocol, only one MRI will be done. In subjects with a questionable history of metallic fragments, an x-ray of the suspected body area will be performed before the MRI to make sure the participants have no metal fragments in their body. In addition to fMRI scanning there are a few other tests that will be administered. This includes a Pre Study Taste Test, in order to prepare them for the fMRI taste task. Participants will be presented five solutions of sucrose (2, 4, 8, 16 and 32 weight by volume) and will then be asked to rate the pleasantness of each solution using a standard seven-point preference scale (i.e., 1=extremely dislike; 7= extremely like). They will also rate perceived sweetness of each solution using a seven-point category scale (i.e., 1=absent; 7=extreme). In addition, they will be presented variants of a tasteless solution Study participants will be asked to choose the solution that has the least taste and this solution will then be used during fMRI scanning. The study takes place over the span of 4 consecutive days on location at the General Clinical Research Center (GCRC) at the University of California in San Diego. During day 1 of the study, lab work would be completed in the morning and several computerized and paper and pencil tasks in the afternoon. Starting at noon of Day 2 and Day 3 of the study, subject participants will undergo two identical 21-hour cycles. In one cycle, study participants will refrain from eating after lunch at 12 noon until 9 a.m. the next morning and they will engage in fMRI studies from 9 to 10:30 a.m. In the other cycle they will be given a standardized diet from noon until 9 a.m. the next day and engage in fMRI studies from 9 to10:30 a.m. The sequence of the two cycles will be randomized across subjects. Caloric consumption will also be regulated. All subjects will receive exactly the same menu over the 4 days of the study. They will eat only when at the GCRC and only when monitored by the GCRC staff. The total daily energy requirement will be calculated as 30 kcal/kg body weight per day with a 53% carbohydrate, 32% fat, 15% protein diet. Water will be provided with the amount consumed recorded. Subjects will be allowed to consume their usual amounts of caffeinated beverages but not allowed to use artificial or natural sweeteners or cream.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anorexia Nervosa, Bulimia Nervosa

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Period of 12 hours where participants eat regulated meals
Arm Title
2
Arm Type
Experimental
Arm Description
Period of 12 hours where participants do not eat anything
Intervention Type
Other
Intervention Name(s)
Imaging
Intervention Description
Imaging - Magnetic Resonance Imaging (MRI) scan of their heads
Intervention Type
Behavioral
Intervention Name(s)
fast
Intervention Description
hungry state - refrain from eating after lunch at 12 noon until 9 a.m. the next morning
Intervention Type
Behavioral
Intervention Name(s)
regulated meals
Intervention Description
standardized diet from noon until 9 a.m. the next day
Primary Outcome Measure Information:
Title
Anterior insula (AI) and orbital frontal cortex (OFC) response to sucrose(relative to ionic water)
Description
fMRI BOLD response
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Must have had a DSM-IV diagnosis of anorexia or bulimia nervosa The onset of their illness must have been at least 4 years prior to participating in this study Must have recovered for 12 months or more prior to entering the study. Exclusion Criteria: Met diagnosis of alcohol or drug abuse or dependence in the 3 months prior to the study. Current diagnosis of a severe major affective or anxiety disorder or presence of other psychopathology that might interfere with ability to participate in the study. Organic brain syndromes, dementia, psychotic disorders or mental retardation Neurological or medical disorders Use of psychoactive medication in the 3 months prior to the study. Pregnancy or lactation, lack of effective birth control during 15 days before the scans.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Walter Kaye, M.D.
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSD General Clinical Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States

12. IPD Sharing Statement

Links:
URL
http://eatingdisorders.ucsd.edu
Description
Related Info

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Neurobiology of Anorexia and Bulimia Nervosa

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