fMRI and Ghlrein in Obesity and Binge Eating Disorder

Obesity Clinical Trial

Official title:

fMRI and Ghlrein in Obesity and Binge Eating Disorder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02038712
• Other study ID #: 06-164
• Status: Completed
• Phase: N/A
• First received: January 10, 2014
• Last updated: January 14, 2014
• Start date: June 2006
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: New York Obesity and Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 93
• Est. completion date: September 2013
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Binge Eating Disorder
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Eating Disorders
• Obesity

Intervention

Dietary Supplement:
• Fed Condition
Subjects will consume a 600mL 600kcal liquid test meal
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
New York Obesity and Nutrition Research Center	Columbia University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI responses to food cues	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.	45 min	No
Secondary	Gut hormone responses	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.	120 min	No
Secondary	Subjective appetite ratings	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	120 min	No