ClinicalTrials.gov
ClinicalTrials.gov Menu

fMRI and Ghlrein in Obesity and Binge Eating Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02038712
Recruitment Status : Completed
First Posted : January 16, 2014
Last Update Posted : January 16, 2014
Sponsor:
Collaborator:
Columbia University
Information provided by (Responsible Party):
Dr. Allan Geliebter, New York Obesity and Nutrition Research Center

Brief Summary:
Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.

Condition or disease Intervention/treatment Phase
Obesity Binge Eating Disorder Dietary Supplement: Fed Condition Dietary Supplement: Fasted condition Procedure: Blood samples Behavioral: Subjective appetite ratings Procedure: fMRI scan Not Applicable

Detailed Description:
Participants will attend the laboratory on two separate occasions following an overnight fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume within 15 min in a randomized crossover design. Blood samples will be collected for during the subsequent 120min to measure the glucose, insulin and gut hormone responses, and subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each of the test drinks so that the appearance in the blood can be used as a proxy measure of gastric emptying. Participants will then undergo a 45min brain scan to assess the responses to visual and auditory food cues.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: fMRI and Ghlrein in Obesity and Binge Eating Disorder
Study Start Date : June 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eating Disorders

Arm Intervention/treatment
Experimental: Binge eating disorder (BED)
Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who meet the current criteria for binge eating disorder (BED) in the fed condition and fasted condition.
Dietary Supplement: Fed Condition
Subjects will consume a 600mL 600kcal liquid test meal
Other Name: Boost (Novartis Nutrition)

Dietary Supplement: Fasted condition
Subjects will consume 600mL plain water.

Procedure: Blood samples
Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min

Behavioral: Subjective appetite ratings
Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.

Procedure: fMRI scan
Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI).

Experimental: Control
Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who do not meet the current criteria for BED (Controls) in the fed condition and fasted condition.
Dietary Supplement: Fed Condition
Subjects will consume a 600mL 600kcal liquid test meal
Other Name: Boost (Novartis Nutrition)

Dietary Supplement: Fasted condition
Subjects will consume 600mL plain water.

Procedure: Blood samples
Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min

Behavioral: Subjective appetite ratings
Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.

Procedure: fMRI scan
Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI).




Primary Outcome Measures :
  1. fMRI responses to food cues [ Time Frame: 45 min ]
    Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition.


Secondary Outcome Measures :
  1. Gut hormone responses [ Time Frame: 120 min ]
    Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min following the ingestion of the liquid test meal and analyzed to determine the gut hormone responses.

  2. Subjective appetite ratings [ Time Frame: 120 min ]
    Subjective ratings of appetite will be collected using a visual analogue scale (VAS) at -15, 0, 10, 30, 60, 90, 120 min following the liquid test meal



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-65 years
  • BMI 30-50 kg/m2
  • Weight stable (<5% change in body weight during past 3 months)
  • Right handed

Exclusion Criteria:

  • Smokers
  • Regular use of medications
  • Current or intended participation in a weight-loss program (diet or exercise)
  • Females who are pregnant or lactating

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02038712


Sponsors and Collaborators
New York Obesity and Nutrition Research Center
Columbia University
Investigators
Principal Investigator: Allan Geliebter, PhD New York Obesity Nutrition Research Center

Responsible Party: Dr. Allan Geliebter, Senior Scientist, New York Obesity and Nutrition Research Center
ClinicalTrials.gov Identifier: NCT02038712     History of Changes
Other Study ID Numbers: 06-164
First Posted: January 16, 2014    Key Record Dates
Last Update Posted: January 16, 2014
Last Verified: January 2014

Keywords provided by Dr. Allan Geliebter, New York Obesity and Nutrition Research Center:
Obesity
Binge eating disorder
fMRI
gut hormones

Additional relevant MeSH terms:
Disease
Feeding and Eating Disorders
Binge-Eating Disorder
Nutrition Disorders
Mental Disorders
Obesity
Bulimia
Pathologic Processes
Overnutrition
Overweight
Body Weight
Signs and Symptoms
Hyperphagia
Signs and Symptoms, Digestive