Brain Activation in Response to Appetitive Cues Pre- and Post- Bariatric Surgery

Obesity Clinical Trial

Official title:

Brain Activation in Response to Appetite Cues Pre- and Post- Bariatric Surgery

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT01590914
• Other study ID #: 08-174
• Status: Enrolling by invitation
• Phase: N/A
• First received: May 1, 2012
• Last updated: March 8, 2013
• Start date: January 2008

Study information

• Verified date: March 2013
• 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

Utilizing fMRI, this study will examine changes in BOLD signal as a proxy measure of brain activation in response to highly palatable (high energy density [kcal/g]), less palatable and non-food stimuli in severely obese women pre, 1 month post and 3 months post undergoing bariatric surgery (in surgery patients) and at equivalent times for control groups in fed and fasted conditions at each time point.

Two surgical groups: (i) laparoscopic Roux-en-Y gastric bypass (RYGB) and (ii) gastric banding (GB) will be compared with two control groups: (i)those enrolled on a 3-month formula weight loss program or (ii) those who qualify, but do not undergo bariatric surgery, and receive no weight loss treatment.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 120
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age > 18 and < 65 years

• BMI > 40 and < 50kg/m2

• Right handed

• Good comprehension of English

Exclusion Criteria:

• > 5% weight fluctuation in the past 3 months

• Presence of disease (including diabetes)

• Pregnancy, lactation or planning to become pregnant in next 18mon

• Smoking, or or recent (within past 12 month) smoking cessation

• Consumption of > 3 alcoholic beverages per day

• Left handed

Study Design

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

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Fed Condition
Subjects will consume a 250ml liquid test meal (250kcal) before undergoing a 40min fMRI scan to assess the BOLD signal responses to visual and auditory responses to food and non-food cues.
• Fasted Condition
Subjects will consume a 250ml control (water) before undergoing a 40min fMRI scan to assess BOLD signal response to visual and auditory food and non-food cues

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York
United States	St Luke's Roosevelt Hospital Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
New York Obesity and Nutrition Research Center	Columbia University, St. Luke's-Roosevelt Hospital Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	BOLD signal response to visual and auditory food cues	BOLD signal changes in the brain in response to highly palatable (high energy density [kcal/g]), less palatable (low energy density)and non-food, stimuli in severely obese women pre-surgery, 1 month post-surgery and 3 months post bariatric surgery	pre-surgery, 1mo post and 3mo post surgery	No