fMRI and Ghlrein in Obesity and Binge Eating Disorder

New York Obesity and Nutrition Research Center

Status: Completed

Conditions: Obesity; Binge Eating Disorder

Treatments: Procedure: Blood samples; Dietary Supplement: Fed Condition; Dietary Supplement: Fasted condition; Procedure: fMRI scan; Behavioral: Subjective appetite ratings

Study type: Interventional

Funder types: Other

Identifiers

NCT02038712

06-164

Details and patient eligibility

About

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.

Full 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.

Enrollment: 93 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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93 participants in 2 patient groups

Binge eating disorder (BED)

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fasted condition

Procedure: Blood samples

Behavioral: Subjective appetite ratings

Procedure: fMRI scan

Dietary Supplement: Fed Condition

Control

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Fasted condition

Procedure: Blood samples

Behavioral: Subjective appetite ratings

Procedure: fMRI scan

Dietary Supplement: Fed Condition